PROTEIN C REAGENT, COAGULOMETRIC— 510(k) K924425

Name: FDA 510(k) clearance K924425
Creator: U.S. Food and Drug Administration
Published: 1995-01-24

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K924425 for PROTEIN C REAGENT, COAGULOMETRIC, Substantially Equivalent on 1995-01-24. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1992-09-01
Decision date: 1995-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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