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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K952307
Device Name BIOSCAN
Applicant
Biosys Laboratories, Inc.
280 S. Atlantic Blvd.
Los Angeles,  CA  90022
Applicant Contact WILLIAM T PIH
Correspondent
Biosys Laboratories, Inc.
280 S. Atlantic Blvd.
Los Angeles,  CA  90022
Correspondent Contact WILLIAM T PIH
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMA   JMT   JRE   LJX  
Date Received05/17/1995
Decision Date 09/05/1995
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
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