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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K891337
Device Name THROMBOSCREEN APTT REAGENT
Applicant
Pacific Hemostasis
2493 Portola Rd.
Ventura,  CA  93003
Applicant Contact FURMAN, PHD
Correspondent
Pacific Hemostasis
2493 Portola Rd.
Ventura,  CA  93003
Correspondent Contact FURMAN, PHD
Regulation Number864.7925
Classification Product Code
GFO  
Date Received03/10/1989
Decision Date 04/21/1989
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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