510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945911Substantially Equivalent

Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agars

Bioclinical Systems, Inc., Annapolis Junction MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945911 is the FDA 510(k) clearance record for CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS, a class II device, cleared for Bioclinical Systems, Inc. on under FDA product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth). FDA records list 13 510(k) clearances for Bioclinical Systems, Inc., from to . As of , FDA records show no recalls naming K945911.

Clearance record

Decision date
Received
(123 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
Bioclinical Systems, Inc. 9040 Junction Dr., Annapolis Junction MD
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