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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
510(k) Number K951122
Device Name CAPITOL URINE DRUG SCREEN COLLECTION KIT
Applicant
Harry A. Schlakman
304 Verona Ave.
Elizabeth,  NJ  07208
Applicant Contact HARRY A SCHLAKMAN
Correspondent
Harry A. Schlakman
304 Verona Ave.
Elizabeth,  NJ  07208
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number864.3250
Classification Product Code
KDW  
Date Received02/27/1995
Decision Date 05/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
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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