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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K130650
Device Name STATUS DS OXY
Applicant
Princeton BioMeditech Corp.
4242 U.S. Hwy. 1
Monmouth Junction,  NJ  08852
Applicant Contact KYUNG-AH KIM
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Hwy. 1
Monmouth Junction,  NJ  08852
Correspondent Contact KYUNG-AH KIM
Regulation Number862.3650
Classification Product Code
DJG  
Date Received03/11/2013
Decision Date 02/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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