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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
Recalls CDRH Recalls
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