510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885341Substantially Equivalent

Titan Gel Alkaline Phosphatase (Hr)

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

K885341 is the FDA 510(k) clearance record for TITAN GEL ALKALINE PHOSPHATASE (HR), a class II device, cleared for Helena Laboratories on under FDA product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K885341.

Clearance record

Decision date
Received
(57 days to decision)
Product code
CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
Third party review
No

Clearances, product code CIN

Trailing 12 months

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

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