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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 K855149
Device Name COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER
Applicant
Hyperion, Inc.
14100 SW 136th St.
Miami,  FL  33186
Applicant Contact HARTER
Correspondent
Hyperion, Inc.
14100 SW 136th St.
Miami,  FL  33186
Correspondent Contact HARTER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received12/26/1985
Decision Date 02/11/1986
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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