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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K973677
Device Name DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
Applicant
Sorrento Biochemical, Inc.
3443 Tripp Ct., Suite A
San Diego,  CA  92121
Applicant Contact ZAK HASSANEIN
Correspondent
Sorrento Biochemical, Inc.
3443 Tripp Ct., Suite A
San Diego,  CA  92121
Correspondent Contact ZAK HASSANEIN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/26/1997
Decision Date 12/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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