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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 K881430
Device Name LIQUI-SERA SERUM ALCOHOL CONTROLS
Applicant
Biodiagnostic Intl
1251 - Q S. Beach Blvd.
La Habra,  CA  90631
Applicant Contact ANAND, PHD
Correspondent
Biodiagnostic Intl
1251 - Q S. Beach Blvd.
La Habra,  CA  90631
Correspondent Contact ANAND, PHD
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/05/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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