510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832613Substantially Equivalent

Mannitol Salt Agar

Carroll Biological Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832613 is the FDA 510(k) clearance record for MANNITOL SALT AGAR, a class I device, cleared for Carroll Biological Corp. on under FDA product code JSJ (Culture Media, Selective And Non-Differential). FDA records list 11 510(k) clearances for Carroll Biological Corp., from to . As of , FDA records show no recalls naming K832613.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JSJ Culture Media, Selective And Non-Differential
Regulation
21 CFR 866.2360
Device class
Class I
Review panel
Microbiology
Applicant
Carroll Biological Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JSJ

Trailing 12 months

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

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