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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K991800
Device Name HEMOCHEK URINE COLLECTION KIT
Applicant
Osborn Group, Inc.
14901 W. 117th St.
Olathe,  KS  66062
Applicant Contact GILBERT P BOURK III
Correspondent
Osborn Group, Inc.
14901 W. 117th St.
Olathe,  KS  66062
Correspondent Contact GILBERT P BOURK III
Regulation Number862.1645
Classification Product Code
JIQ  
Subsequent Product Codes
CGX   FMH  
Date Received05/26/1999
Decision Date 09/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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