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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K864643
Device Name GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
Applicant
Pacific Hemostasis
2493 Portola Rd.
Ventura,  CA  93003
Applicant Contact BICK, PHD
Correspondent
Pacific Hemostasis
2493 Portola Rd.
Ventura,  CA  93003
Correspondent Contact BICK, PHD
Regulation Number864.7470
Classification Product Code
LCP  
Date Received11/26/1986
Decision Date 04/28/1987
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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