510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895528Substantially Equivalent

Gel Alkaline Phosphatase Isoenzyme Control No.5104

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

K895528 is the FDA 510(k) clearance record for GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104, a class I device, cleared for Helena Laboratories on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show one recall naming K895528.

Clearance record

Decision date
Received
(49 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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