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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Fibrinogen Control
510(k) Number K935598
Device Name PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
Applicant
Clinical Controls, Inc.
750 Farroll Rd.
Suite B
Grover Beach,  CA  93433
Applicant Contact JAMES F GODFREY
Correspondent
Clinical Controls, Inc.
750 Farroll Rd.
Suite B
Grover Beach,  CA  93433
Correspondent Contact JAMES F GODFREY
Regulation Number864.7340
Classification Product Code
GIL  
Date Received11/19/1993
Decision Date 05/02/1995
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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