510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K772356Substantially Equivalent

Ldh Isoenzyme Column Reagent Set

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

K772356 is the FDA 510(k) clearance record for LDH ISOENZYME COLUMN REAGENT SET, a class II device, cleared for Worthington Biochemical Corp. on under FDA product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes). FDA records list 13 510(k) clearances for Worthington Biochemical Corp., from to . As of , FDA records show no recalls naming K772356.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Worthington Biochemical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CEX

Trailing 12 months

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

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