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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Pressure Liquid Chromatography, Methamphetamine
510(k) Number K062575
Device Name MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
Applicant
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852 -1905
Applicant Contact KYUNG-AH KIM
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852 -1905
Correspondent Contact KYUNG-AH KIM
Regulation Number862.3610
Classification Product Code
LAG  
Subsequent Product Codes
DIO   DIS   DJG   DJR   DKE  
DKZ   JXM   LCM   LFI  
Date Received08/31/2006
Decision Date 11/26/2007
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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