Siemens Healthcare Diagnostics, Inc.: PMA supplement approved for ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP)
Siemens Healthcare Diagnostics, Inc. (East Walpole, Massachusetts): PMA supplement approved for ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP). Dated 178 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 36 related MA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Siemens Healthcare Diagnostics, Inc. |
| Product | ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) |
| Generic / ingredient | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Approval | PMA supplement (device change) |
| Application | P930036 S026 |
| Decided | 2026-05-11 |
| Panel / class | Immunology |
| Sponsor location | East Walpole, MA |
| Peer records CSV (37 MA records) | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-05-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Siemens Healthcare Diagnostics, Inc. and 37 Massachusetts peers
- Massachusetts FdaApprovalPulse records like this one: 37
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $7,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Siemens Healthcare Diagnostics, Inc. in East Walpole, Massachusetts?
The FDA approved ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036 S026) for Siemens Healthcare Diagnostics, Inc. on 2026-05-11: PMA supplement (device change).
How does Siemens Healthcare Diagnostics, Inc. compare to other Massachusetts FdaApprovalPulse records?
It is 178 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Siemens Healthcare Diagnostics, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Siemens Healthcare Diagnostics, Inc. | East Walpole, MA | 2026-05-11 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Instylla, Inc. | Bedford, MA | 2026-10-21 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.