510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850731Substantially Equivalent

Culture Medium for Antimicrobial Suscep. Testing

Roseville Medical Laboratoriesu, Roseville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850731 is the FDA 510(k) clearance record for CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING, a class II device, cleared for Roseville Medical Laboratoriesu on under FDA product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth). FDA records list 8 510(k) clearances for Roseville Medical Laboratoriesu, from to . As of , FDA records show no recalls naming K850731.

Clearance record

Decision date
Received
(28 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
Roseville Medical Laboratoriesu 729 Sunrise, Blvd., Roseville CA
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