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
K905650Substantially Equivalent

Kinetic Alkaline Phosphatase Determination

Biochemical Trade, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905650 is the FDA 510(k) clearance record for KINETIC ALKALINE PHOSPHATASE DETERMINATION, a class II device, cleared for Biochemical Trade, Inc. on under FDA product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes). FDA records list 20 510(k) clearances for Biochemical Trade, Inc., from to . As of , FDA records show no recalls naming K905650.

Clearance record

Decision date
Received
(57 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
Biochemical Trade, Inc. 7522 NW 55th St., Miami FL
Third party review
No

Clearances, product code CJE

Trailing 12 months
1 clearance under product code CJE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CJE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260