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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K933970
Device Name N-ASSAY TIA IGM
Applicant
Crestat Diagnostics, Inc.
822 Hampshire Rd.
Unit C
Thousand Oaks,  CA  91361
Applicant Contact MARY REES
Correspondent
Crestat Diagnostics, Inc.
822 Hampshire Rd.
Unit C
Thousand Oaks,  CA  91361
Correspondent Contact MARY REES
Regulation Number866.5510
Classification Product Code
CFN  
Date Received08/13/1993
Decision Date 03/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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