COULTER DIRECT BILIRUBIN— 510(k) K902199

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K902199 for COULTER DIRECT BILIRUBIN, Substantially Equivalent on 1990-06-12. Applicant: Coulter Corp..

Clearance details

Applicant: Coulter Corp.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1990-05-16
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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