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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 K984529
Device Name HEMOCHEK SAMPLE COLLECTION KIT
Applicant
Osborn Laboratories, Inc.
14901 W. 117th St.
Olathe,  KS  66062
Applicant Contact GILBERT P BOURKE III
Correspondent
Osborn Laboratories, Inc.
14901 W. 117th St.
Olathe,  KS  66062
Correspondent Contact GILBERT P BOURKE III
Regulation Number864.7470
Classification Product Code
LCP  
Date Received12/21/1998
Decision Date 01/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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