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
K902543Substantially Equivalent

Acid Phosphotase Reagent Test and Kit

Crestat Diagnostics, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902543 is the FDA 510(k) clearance record for ACID PHOSPHOTASE REAGENT TEST AND KIT, a class II device, cleared for Crestat Diagnostics, Inc. on under FDA product code CKB (Acid Phosphatase, Naphthyl Phosphate). FDA records list 29 510(k) clearances for Crestat Diagnostics, Inc., from to . As of , FDA records show no recalls naming K902543.

Clearance record

Decision date
Received
(93 days to decision)
Product code
CKB Acid Phosphatase, Naphthyl Phosphate
Regulation
21 CFR 862.1020
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Crestat Diagnostics, Inc. P.O. Box 18225, Portland OR
Third party review
No

Clearances, product code CKB

Trailing 12 months

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

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