510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K791546Substantially Equivalent

Columbia Cna Blood Agar

Isle Media and Sterile Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791546 is the FDA 510(k) clearance record for COLUMBIA CNA BLOOD AGAR, a class I device, cleared for Isle Media and Sterile Products, Inc. on under FDA product code JSR (Kit, Identification, Dermatophyte). FDA records list 93 510(k) clearances for Isle Media and Sterile Products, Inc., from to . As of , FDA records show no recalls naming K791546.

Clearance record

Decision date
Received
(38 days to decision)
Product code
JSR Kit, Identification, Dermatophyte
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Isle Media and Sterile Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JSR

Trailing 12 months

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

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