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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 K923844
Device Name LYRIS 100/120 LABORATORY INFORMATION SYSTEM
Applicant
Biovation, Inc.
875alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact EDWIN O BROWN
Correspondent
Biovation, Inc.
875alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact EDWIN O BROWN
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/31/1992
Decision Date 12/11/1992
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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