510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844547Substantially Equivalent

Tryptic Soy Broth W/6.5%sodium Chloride

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

K844547 is the FDA 510(k) clearance record for TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE, a class I device, cleared for bioMerieux, Inc. on under FDA product code JSD (Culture Media, Selective Broth). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K844547.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JSD Culture Media, Selective Broth
Regulation
21 CFR 866.2360
Device class
Class I
Review panel
Microbiology
Applicant
bioMerieux, Inc. 421 Irmen Dr., Addison IL
Third party review
No

Clearances, product code JSD

Trailing 12 months

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

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