510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900216Substantially Equivalent

Coulter Alp (Alk Phos) Reagent

Coulter Corp., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900216 is the FDA 510(k) clearance record for COULTER ALP (ALK PHOS) REAGENT, a class II device, cleared for Coulter Corp. on under FDA product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes). FDA records list 51 510(k) clearances for Coulter Corp., from to . As of , FDA records show no recalls naming K900216.

Clearance record

Decision date
Received
(22 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
Coulter Corp. 745 W. 83rd St., Hialeah 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