AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT

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 Auto Eia Microplate Read Model Ceres 900 W/var Opt.

Pre-market Notification Details

Device IDK914906
510k NumberK914906
Device Name:AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT
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 Received1991-11-01
Decision Date1991-11-27

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