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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 K935983
Device Name MICROREADER 4
Applicant
HYPERION, INC.
14100 S.W. 136TH ST.
MIAMI,  FL  33186
Applicant Contact G. GREGORY STAMATIS
Correspondent
HYPERION, INC.
14100 S.W. 136TH ST.
MIAMI,  FL  33186
Correspondent Contact G. GREGORY STAMATIS
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received12/14/1993
Decision Date 12/09/1994
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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