COAMATE PROTEIN C CHROMOGENIC ASSAY— 510(k) K922201

Substantially Equivalent

Chromogenix AB

FDA 510(k) clearance K922201 for COAMATE PROTEIN C CHROMOGENIC ASSAY, Substantially Equivalent on 1992-12-07. Applicant: Chromogenix AB.

Clearance details

Applicant: Chromogenix AB
Product code: Code GGP
Advisory panel: Hematology
Date received: 1992-05-11
Decision date: 1992-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molndal, SE

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