510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962609Substantially Equivalent

Gram Negative Identification Plus Card

Biomerieux Vitek, Inc., Hazelwood MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962609 is the FDA 510(k) clearance record for GRAM NEGATIVE IDENTIFICATION PLUS CARD, a class I device, cleared for Biomerieux Vitek, Inc. on under FDA product code LRH (Instrument For Auto Reader Of Overnight Microorganism Identification System). FDA records list 49 510(k) clearances for Biomerieux Vitek, Inc., from to . As of , FDA records show no recalls naming K962609.

Clearance record

Decision date
Received
(58 days to decision)
Product code
LRH Instrument For Auto Reader Of Overnight Microorganism Identification System
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Biomerieux Vitek, Inc. 595 Anglum Dr., Hazelwood MO
510(k) summary
Summary
Third party review
No

Clearances, product code LRH

Trailing 12 months

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

FDA records show no clearances under product code LRH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRH, 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