510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821983Substantially Equivalent

Titan Gel Ldh Isoenzyme Kit

Helena Laboratories, Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821983 is the FDA 510(k) clearance record for TITAN GEL LDH ISOENZYME KIT, a class II device, cleared for Helena Laboratories on under FDA product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K821983.

Clearance record

Decision date
Received
(169 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
Helena Laboratories 4221 Richmond Rd., NW, Walker MI
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