510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941985Substantially Equivalent

Mueller Hinton Agar W/oxacillin

Carr-Scarborough Microbiologicals, Inc., Stone Mountain GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941985 is the FDA 510(k) clearance record for MUELLER HINTON AGAR W/OXACILLIN, a class II device, cleared for Carr-Scarborough Microbiologicals, Inc. on under FDA product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth). FDA records list 24 510(k) clearances for Carr-Scarborough Microbiologicals, Inc., from to . As of , FDA records show no recalls naming K941985.

Clearance record

Decision date
Received
(121 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
Carr-Scarborough Microbiologicals, Inc. P.O. Box 1328, Stone Mountain GA
510(k) summary
Statement
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