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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 K990899
Device Name HEMOCHEK-A1C SAMPLE COLLECTION KIT
Applicant
OSBORN GROUP, INC.
14901 WEST 117TH ST.
OLATHE,  KS  66062
Applicant Contact GILBERT P BOURK III
Correspondent
OSBORN GROUP, INC.
14901 WEST 117TH ST.
OLATHE,  KS  66062
Correspondent Contact GILBERT P BOURK III
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/18/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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