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VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc. vs VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.: FDAPulse comparison

VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.'s review days of 245 is 1.1x VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.'s 215 (78th percentile). VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc. is dated 2026-10-01; VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc. 2026-09-28.

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

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How does VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc. compare to VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.?

FieldVITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK260283K260619
DeviceVITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
ApplicantbioMerieux, Inc.Biomérieux, Inc.
Specialty / panelMicrobiologyMicrobiology
Product codeLONLON
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-01-292026-02-25
Decision date2026-10-012026-09-28
Review time (days)245215
Third-party reviewNoNo
Applicant locationHazelwood, MO, USHazelwood, MO, US
amount percentile78th69th
Predicate Speed & CAPA Advisory Opportunity Score61/10048/100
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Official records: VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc. · VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.

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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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