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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumocystis Carinii
510(k) Number K992252
Device Name LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
Applicant
Chemicon Intl., Inc.
28835 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact CINDY PENNY
Correspondent
Chemicon Intl., Inc.
28835 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact CINDY PENNY
Regulation Number866.3780
Classification Product Code
LYF  
Date Received07/06/1999
Decision Date 08/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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