510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944554Substantially Equivalent

Brain Heart Infusion Agar

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

K944554 is the FDA 510(k) clearance record for BRAIN HEART INFUSION AGAR, a class II device, cleared for Carr-Scarborough Microbiologicals, Inc. on under FDA product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar). FDA records list 24 510(k) clearances for Carr-Scarborough Microbiologicals, Inc., from to . As of , FDA records show no recalls naming K944554.

Clearance record

Decision date
Received
(18 days to decision)
Product code
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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 JSO

Trailing 12 months

FDA records hold no clearances under product code JSO in the trailing twelve months.

FDA records show no clearances under product code JSO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JSO, 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 20260
October 20260