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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Giardia Spp.
510(k) Number K912152
Device Name CELLABS GIARDIA CEL I.F. TEST
Applicant
Celltech Diagnostics , Ltd.
C/O Baker & Hostetler
1050 Connecticute Ave., NW
Suite 11oo, Washington,  DC  20036
Applicant Contact BRUCE F MACKLER
Correspondent
Celltech Diagnostics , Ltd.
C/O Baker & Hostetler
1050 Connecticute Ave., NW
Suite 11oo, Washington,  DC  20036
Correspondent Contact BRUCE F MACKLER
Regulation Number866.3220
Classification Product Code
MHI  
Date Received05/15/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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