510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K923507Substantially Equivalent

Alkaline Phosphatase Kit

Randox Laboratories, Limited, Antrim, N. Ireland, IR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923507 is the FDA 510(k) clearance record for ALKALINE PHOSPHATASE KIT, a class II device, cleared for Randox Laboratories, Ltd. on under FDA product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show no recalls naming K923507.

Clearance record

Decision date
Received
(141 days to decision)
Product code
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Randox Laboratories, Ltd. Ardmore, Diamond Rd., Antrim, N. Ireland, IR
510(k) summary
Statement
Third party review
No

Clearances, product code CJE

Trailing 12 months
1 clearance under product code CJE in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CJE, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260