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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K970189
Device Name FIF TM
Applicant
Panbio, Inc.
1539 N. Ironwood Dr.
South Bend,  IN  46635
Applicant Contact LINDA M WILLIAMS
Correspondent
Panbio, Inc.
1539 N. Ironwood Dr.
South Bend,  IN  46635
Correspondent Contact LINDA M WILLIAMS
Regulation Number864.7340
Classification Product Code
KQJ  
Subsequent Product Code
GIS  
Date Received01/21/1997
Decision Date 05/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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