510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971825Substantially Equivalent

Pancreatic Amylase, Ethylidene Blocked-Pnpg7 Enzyme Colorimetric Test

Randox Laboratories, Limited, Crumlin, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971825 is the FDA 510(k) clearance record for PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST, a class II device, cleared for Randox Laboratories, Ltd. on under FDA product code JFJ (Catalytic Methods, Amylase). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show one recall naming K971825.

Clearance record

Decision date
Received
(69 days to decision)
Product code
JFJ Catalytic Methods, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Randox Laboratories, Ltd. Ardmore, Diamond Rd., Crumlin, IE
510(k) summary
Statement
Third party review
No

Clearances, product code JFJ

Trailing 12 months

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

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