BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL— 510(k) K930267

Name: FDA 510(k) clearance K930267
Creator: U.S. Food and Drug Administration
Published: 1994-03-22

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K930267 for BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL, Substantially Equivalent on 1994-03-22. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1993-01-19
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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