510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183415Substantially Equivalent

VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)

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

K183415 is the FDA 510(k) clearance record for VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL), a class II device, cleared for bioMerieux, Inc. on under FDA product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show one recall naming K183415.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Regulation
21 CFR 866.1645
Device class
Class II
Review panel
Microbiology
Applicant
bioMerieux, Inc. 595 Anglum Rd., Hazelwood MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LON

Trailing 12 months
2 clearances under product code LON in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LON, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260