COULTER GAMMA-GT (GGT) REAGENT— 510(k) K901264

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K901264 for COULTER GAMMA-GT (GGT) REAGENT, Substantially Equivalent on 1990-04-16. Applicant: Coulter Corp..

Clearance details

Applicant: Coulter Corp.
Product code: Code JQB
Advisory panel: Clinical Chemistry
Date received: 1990-03-16
Decision date: 1990-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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