DeviceClearance

HEMOLAB— 510(k) K931992

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K931992 for HEMOLAB, Substantially Equivalent on 1994-12-22. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant
Biomerieux Vitek, Inc.
Product code
Code GKP
Device class
Class 2
Regulation
21 CFR 864.5400
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hazelwood, MO, US
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