Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name High Pressure Liquid Chromatography, Methamphetamine
510(k) Number K983501
Device Name ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/
Applicant
Princeton BioMeditech Corp.
P.O. Box 7139
Princeton,  NJ  08543
Applicant Contact JEMO KANG
Correspondent
Princeton BioMeditech Corp.
P.O. Box 7139
Princeton,  NJ  08543
Correspondent Contact JEMO KANG
Regulation Number862.3610
Classification Product Code
LAG  
Subsequent Product Codes
DIO   DIS   DJG   DJR   DKE  
DKN   DKZ   LCM   LFI  
Date Received10/06/1998
Decision Date 12/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-