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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 K863744
Device Name HCG CONTROL KIT
Applicant
Monoclonal Antibodies, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact MICHAEL C MALONEY
Correspondent
Monoclonal Antibodies, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact MICHAEL C MALONEY
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/24/1986
Decision Date 11/05/1986
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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