COAMATE PROTEIN C CHROMOGENIC ASSAY— 510(k) K922201

Name: FDA 510(k) clearance K922201
Creator: U.S. Food and Drug Administration
Published: 1992-12-07

Substantially Equivalent

Chromogenix AB

FDA 510(k) clearance K922201 for COAMATE PROTEIN C CHROMOGENIC ASSAY, Substantially Equivalent on 1992-12-07. Applicant: Chromogenix AB. Device class: 2.

Clearance details

Applicant: Chromogenix AB
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1992-05-11
Decision date: 1992-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molndal, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.