COULTER SERUM IRON/UIBC REAGENT— 510(k) K902173

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K902173 for COULTER SERUM IRON/UIBC REAGENT, Substantially Equivalent on 1990-06-12. Applicant: Coulter Corp.. Device class: 1.

Clearance details

Applicant: Coulter Corp.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1990-05-14
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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