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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
510(k) Number K964299
Device Name N-ASSAY TIA MULTI V-NL
Applicant
Crestat Diagnostics, Inc.
25549 Adams Ave.
Murrieta,  CA  92562
Correspondent
Crestat Diagnostics, Inc.
25549 Adams Ave.
Murrieta,  CA  92562
Regulation Number866.5420
Classification Product Code
LKL  
Date Received10/29/1996
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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