AUTOMATED EIA READER MODEL EL311

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 Automated Eia Reader Model El311.

Pre-market Notification Details

Device IDK884124
510k NumberK884124
Device Name:AUTOMATED EIA READER MODEL EL311
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski,  VT  05404
ContactDan Contois
CorrespondentDan Contois
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 Received1988-09-30
Decision Date1989-01-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.