BIOMERIEUX HEMOLAB THROMBICALCI-TEST— 510(k) K925493

Name: FDA 510(k) clearance K925493
Creator: U.S. Food and Drug Administration
Published: 1994-04-21

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K925493 for BIOMERIEUX HEMOLAB THROMBICALCI-TEST, Substantially Equivalent on 1994-04-21. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1992-11-02
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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