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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Sickle Cell
510(k) Number K854079
Device Name THROMBO SCREEN SICKLE CELL ASSAY SET
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 Number864.7825
Classification Product Code
GHM  
Date Received10/07/1985
Decision Date 10/31/1985
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
Recalls CDRH Recalls
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