510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162385Substantially Equivalent

Rapidec Carba Np

bioMerieux, Inc., Craponne, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162385 is the FDA 510(k) clearance record for RAPIDEC CARBA NP, a class II device, cleared for Biomerieux S.A. on under FDA product code PTJ (Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates). FDA's definition for product code PTJ reads: "Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem". FDA records list 408 510(k) clearances for Biomerieux S.A., from to . As of , FDA records show no recalls naming K162385.

Clearance record

Decision date
Received
(245 days to decision)
Product code
PTJ Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Biomerieux S.A. 5 Rue Des Aqueducs, Craponne, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PTJ

Trailing 12 months

FDA records hold no clearances under product code PTJ in the trailing twelve months.

FDA records show no clearances under product code PTJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PTJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260