COULTER ALP (ALK PHOS) REAGENT— 510(k) K900216

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K900216 for COULTER ALP (ALK PHOS) REAGENT, Substantially Equivalent on 1990-02-08. Applicant: Coulter Corp.. Device class: 2.

Clearance details

Applicant: Coulter Corp.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1990-01-17
Decision date: 1990-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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