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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 K913967
Device Name DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
Applicant
Doxtech, Inc.
4000 Easton Dr., #10
Bakersfield,  CA  93309
Applicant Contact STANLEY D OGDEN
Correspondent
Doxtech, Inc.
4000 Easton Dr., #10
Bakersfield,  CA  93309
Correspondent Contact STANLEY D OGDEN
Regulation Number864.3250
Classification Product Code
KDW  
Date Received09/05/1991
Decision Date 10/18/1991
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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