510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823211Substantially Equivalent

Ck-UV Reagent

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

K823211 is the FDA 510(k) clearance record for CK-UV REAGENT, a class II device, cleared for Biorent Diagnostic, Inc. on under FDA product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes). FDA records list 11 510(k) clearances for Biorent Diagnostic, Inc., from to . As of , FDA records show no recalls naming K823211.

Clearance record

Decision date
Received
(25 days to decision)
Product code
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
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 JHS

Trailing 12 months

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

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