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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinopeptide A, Antigen, Antiserum, Control
510(k) Number K884496
Device Name RIA/MAT FPA TEST KIT
Applicant
Altana, Inc.
60 Baylis Rd.
Melville,  NY  11747
Applicant Contact CLAIR, PHD
Correspondent
Altana, Inc.
60 Baylis Rd.
Melville,  NY  11747
Correspondent Contact CLAIR, PHD
Regulation Number866.5350
Classification Product Code
DAN  
Date Received10/25/1988
Decision Date 11/16/1988
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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