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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K932657
Device Name FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
Applicant
More Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Applicant Contact JAMES W SNIPES
Correspondent
More Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Correspondent Contact JAMES W SNIPES
Regulation Number864.7320
Classification Product Code
DAP  
Date Received06/02/1993
Decision Date 11/02/1993
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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