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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrin Split Products
510(k) Number K852512
Device Name THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
Applicant
PACIFIC HEMOSTASIS
2493 PORTOLA RD.
VENTURA,  CA  93003
Applicant Contact MICHAEL D BICK
Correspondent
PACIFIC HEMOSTASIS
2493 PORTOLA RD.
VENTURA,  CA  93003
Correspondent Contact MICHAEL D BICK
Regulation Number864.7320
Classification Product Code
GHH  
Date Received06/12/1985
Decision Date 09/17/1985
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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