ELX800 AND EL800 AUTOMATED MICROPLATE READERS

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 Elx800 And El800 Automated Microplate Readers.

Pre-market Notification Details

Device IDK950104
510k NumberK950104
Device Name:ELX800 AND EL800 AUTOMATED MICROPLATE READERS
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski,  VT  05404 -0998
ContactMichael N Sevigny
CorrespondentMichael N Sevigny
BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski,  VT  05404 -0998
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-11
Decision Date1995-03-21

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