510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791194Substantially Equivalent

Brain Heart Infusion Broth

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

K791194 is the FDA 510(k) clearance record for BRAIN HEART INFUSION BROTH, a class I device, cleared for Isle Media and Sterile Products, Inc. on under FDA product code JSC (Culture Media, General Nutrient Broth). FDA records list 93 510(k) clearances for Isle Media and Sterile Products, Inc., from to . As of , FDA records show no recalls naming K791194.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JSC Culture Media, General Nutrient Broth
Regulation
21 CFR 866.2350
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 JSC

Trailing 12 months

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

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