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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Fibrinogen
510(k) Number K910636
Device Name ABS CADKIT
Applicant
Panbio, Inc.
C/O Baker & Hostetler
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact MICHA BARACH
Correspondent
Panbio, Inc.
C/O Baker & Hostetler
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact MICHA BARACH
Regulation Number864.7340
Classification Product Code
GIS  
Date Received02/13/1991
Decision Date 04/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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