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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K933548
Device Name ELS 1000
Applicant
Bio-Tek Instruments, Inc.
Highland Park
P.O. Box 998
Winooski,  VT  05404
Applicant Contact MICHAEL N SEVIGNY
Correspondent
Bio-Tek Instruments, Inc.
Highland Park
P.O. Box 998
Winooski,  VT  05404
Correspondent Contact MICHAEL N SEVIGNY
Regulation Number862.2160
Classification Product Code
JJE  
Date Received07/20/1993
Decision Date 10/29/1993
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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