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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K942647
Device Name COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI
Applicant
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee,  CA  92071
Applicant Contact THOMAS CANTOR
Correspondent
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee,  CA  92071
Correspondent Contact THOMAS CANTOR
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/03/1994
Decision Date 07/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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