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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 K925625
Device Name OMNI
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 Received11/06/1992
Decision Date 08/19/1993
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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