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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Clostridium Difficile Toxin
510(k) Number K990664
Device Name PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
Applicant
Intracel Corp.
1330 Piccard Dr.
Rockville,  MD  20850
Applicant Contact CECILIA MATOS-ROSA
Correspondent
Intracel Corp.
1330 Piccard Dr.
Rockville,  MD  20850
Correspondent Contact CECILIA MATOS-ROSA
Regulation Number866.2660
Classification Product Code
LLH  
Date Received03/01/1999
Decision Date 03/31/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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