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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K901027
Device Name AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
Applicant
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Applicant Contact MICHAEL N SEVIGNY
Correspondent
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Correspondent Contact MICHAEL N SEVIGNY
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/06/1990
Decision Date 04/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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