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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 K950104
Device Name ELX800 AND EL800 AUTOMATED MICROPLATE READERS
Applicant
Bio-Tek Instruments, Inc.
Highland Park
P.O. Box 998
Winooski,  VT  05404 -0998
Applicant Contact MICHAEL N SEVIGNY
Correspondent
Bio-Tek Instruments, Inc.
Highland Park
P.O. Box 998
Winooski,  VT  05404 -0998
Correspondent Contact MICHAEL N SEVIGNY
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received01/11/1995
Decision Date 03/21/1995
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
Recalls CDRH Recalls
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