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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-Antitrypsin, Antigen, Antiserum, Control
510(k) Number K965100
Device Name N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
Applicant
Crestat Diagnostics, Inc.
374 Goodhill Rd.
Weston,  CT  06883
Applicant Contact MARY REES
Correspondent
Crestat Diagnostics, Inc.
374 Goodhill Rd.
Weston,  CT  06883
Correspondent Contact MARY REES
Regulation Number866.5130
Classification Product Code
DEM  
Date Received12/20/1996
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
Recalls CDRH Recalls
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