510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871096Substantially Equivalent

Cystine Tryptic Agar W/o Carbohydrates

bioMerieux, Inc., Addison IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871096 is the FDA 510(k) clearance record for CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES, a class I device, cleared for bioMerieux, Inc. on under FDA product code JSE (Culture Media, Multiple Biochemical Test). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K871096.

Clearance record

Decision date
Received
(16 days to decision)
Product code
JSE Culture Media, Multiple Biochemical Test
Regulation
21 CFR 866.2320
Device class
Class I
Review panel
Microbiology
Applicant
bioMerieux, Inc. 421 Irmen Dr., Addison IL
Third party review
No

Clearances, product code JSE

Trailing 12 months

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

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