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Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics vs Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics: FDAPulse comparison

Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics's review days of 249 is 1.0x Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics's 249 (79th percentile). Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics is dated 2026-10-02; Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics 2026-10-02.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics compare to Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics?

FieldElecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche DiagnosticsElecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
Record510(k) clearance510(k) clearance
510(k) numberK260221K260232
DeviceElecsys EBV EBNA IgGElecsys EBV VCA IgG
ApplicantRoche DiagnosticsRoche Diagnostics
Specialty / panelMicrobiologyMicrobiology
Product codeLSELSE
Device class11
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-01-262026-01-26
Decision date2026-10-022026-10-02
Review time (days)249249
Third-party reviewNoNo
Applicant locationIndianapolis, IN, USIndianapolis, IN, US
amount percentile79th79th
Predicate Speed & CAPA Advisory Opportunity Score61/10061/100
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Official records: Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics · Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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