FDP - SLIDEX DIRECT— 510(k) K921989

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K921989 for FDP - SLIDEX DIRECT, Substantially Equivalent on 1993-11-03. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1992-04-28
Decision date: 1993-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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