510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820794Substantially Equivalent

#19012 Chocolate Mueller Hinton-150X15mm

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

K820794 is the FDA 510(k) clearance record for #19012 CHOCOLATE MUELLER HINTON-150X15MM, a class II device, cleared for Biomedica, Inc. on under FDA product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth). FDA records list 19 510(k) clearances for Biomedica, Inc. As of , FDA records show no recalls naming K820794.

Clearance record

Decision date
Received
(16 days to decision)
Product code
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Regulation
21 CFR 866.1700
Device class
Class II
Review panel
Microbiology
Applicant
Biomedica, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTZ

Trailing 12 months
1 clearance under product code JTZ in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JTZ, 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 20261
October 20260