TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE— 510(k) K911438

Name: FDA 510(k) clearance K911438
Creator: U.S. Food and Drug Administration
Published: 1991-05-23

Substantially Equivalent

Bio-Tek Instruments, Inc.

FDA 510(k) clearance K911438 for TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE, Substantially Equivalent on 1991-05-23. Applicant: Bio-Tek Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Tek Instruments, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1991-04-02
Decision date: 1991-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winooski, VT, US

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