TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE

Colorimeter, Photometer, Spectrophotometer For Clinical Use

BIO-TEK INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Turbo Accelerator W/clin Diag Software Cartridge.

Pre-market Notification Details

Device IDK911438
510k NumberK911438
Device Name:TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski,  VT  05404
ContactMichael N Sevigny
CorrespondentMichael N Sevigny
BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski,  VT  05404
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-02
Decision Date1991-05-23

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