COULTER PHOSPHORUS REAGENT— 510(k) K900215

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K900215 for COULTER PHOSPHORUS REAGENT, Substantially Equivalent on 1990-02-08. Applicant: Coulter Corp.. Device class: 1.

Clearance details

Applicant: Coulter Corp.
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
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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