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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K853887
Device Name LIQUI-SERA CHEM. MULTIPLE CALIBRATORS
Applicant
Biodiagnostic Intl
1251 - Q S. Beach Blvd.
La Habra,  CA  90631
Applicant Contact PAUL ANAND
Correspondent
Biodiagnostic Intl
1251 - Q S. Beach Blvd.
La Habra,  CA  90631
Correspondent Contact PAUL ANAND
Regulation Number862.1150
Classification Product Code
JIT  
Date Received09/19/1985
Decision Date 09/30/1985
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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