510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863821Substantially Equivalent

Mueller Hinton Agar W/4%nacl and Oxacillin

Gibco Laboratories Life Technologies, Inc., Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863821 is the FDA 510(k) clearance record for MUELLER HINTON AGAR W/4%NACL AND OXACILLIN, a class II device, cleared for Gibco Laboratories Life Technologies, Inc. on under FDA product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth). FDA records list 67 510(k) clearances for Gibco Laboratories Life Technologies, Inc., from to . As of , FDA records show one recall naming K863821.

Clearance record

Decision date
Received
(9 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
Gibco Laboratories Life Technologies, Inc. 2801 Industrial Dr., Madison WI
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