510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820768Substantially Equivalent

Colorimetric Ldh Reagent Set

Biorent Diagnostic, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820768 is the FDA 510(k) clearance record for COLORIMETRIC LDH REAGENT SET, a class II device, cleared for Biorent Diagnostic, Inc. on under FDA product code CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase). FDA records list 11 510(k) clearances for Biorent Diagnostic, Inc., from to . As of , FDA records show no recalls naming K820768.

Clearance record

Decision date
Received
(23 days to decision)
Product code
CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Regulation
21 CFR 862.1440
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biorent Diagnostic, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CFH

Trailing 12 months

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

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