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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Blood Collection
510(k) Number K925468
Device Name JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT
Applicant
J.J. Skinner, Inc.
C/O Medical Device Inspection
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
J.J. Skinner, Inc.
C/O Medical Device Inspection
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number862.1675
Classification Product Code
GJE  
Date Received10/29/1992
Decision Date 04/11/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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