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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
510(k) Number K963318
Device Name LEGIONELLA IGG/IGM ELISA TEST SYSTEM
Applicant
Armkel, LLC
1306f Bailes Ln.
Frederick,  MD  21701
Applicant Contact WILLIAM L BOTELER JR.
Correspondent
Armkel, LLC
1306f Bailes Ln.
Frederick,  MD  21701
Correspondent Contact WILLIAM L BOTELER JR.
Regulation Number866.3300
Classification Product Code
LHL  
Date Received08/23/1996
Decision Date 03/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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