510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843380Substantially Equivalent

Acid Phosphatase Assay Kit

Diagnostic Chemicals, Ltd. (USA), Canada / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843380 is the FDA 510(k) clearance record for ACID PHOSPHATASE ASSAY KIT, a class II device, cleared for Diagnostic Chemicals, Ltd. (Usa) on under FDA product code CKE (Acid Phosphatase, Thymolphthale Inmonophosphate). FDA records list 77 510(k) clearances for Diagnostic Chemicals, Ltd. (Usa), from to . As of , FDA records show no recalls naming K843380.

Clearance record

Decision date
Received
(23 days to decision)
Product code
CKE Acid Phosphatase, Thymolphthale Inmonophosphate
Regulation
21 CFR 862.1020
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals, Ltd. (Usa) 4 Newland Crescent, Canada
Third party review
No

Clearances, product code CKE

Trailing 12 months

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

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