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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 K915814
Device Name SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS
Applicant
Sirchie Finger Print Laboratories, Inc.
P.O. Box 30576
Raleigh,  NC  27622
Applicant Contact JAMES W GOCKE
Correspondent
Sirchie Finger Print Laboratories, Inc.
P.O. Box 30576
Raleigh,  NC  27622
Correspondent Contact JAMES W GOCKE
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/30/1991
Decision Date 03/27/1992
Decision Substantially Equivalent - Kit (SESK)
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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