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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K993787
Device Name APPRAISE-CARDIO 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 Number862.1675
Classification Product Code
JKA  
Date Received11/09/1999
Decision Date 04/14/2000
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
Recalls CDRH Recalls
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