COULTER DIRECT BILLRUBIN REAGENT— 510(k) K905622

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K905622 for COULTER DIRECT BILLRUBIN REAGENT, Substantially Equivalent on 1990-12-26. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1990-12-14
Decision date: 1990-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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