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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K961764
Device Name PR-3 ELISA TEST SYSTEM
Applicant
Immunoprobe, Inc.
1306f Bailes Ln.
Frederick,  MD  21701
Applicant Contact WILLIAM L BOTELER JR.
Correspondent
Immunoprobe, Inc.
1306f Bailes Ln.
Frederick,  MD  21701
Correspondent Contact WILLIAM L BOTELER JR.
Regulation Number866.5660
Classification Product Code
MOB  
Date Received05/07/1996
Decision Date 08/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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