The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 10,accusign Doa Panel,accusign Met/opi/coc/thc/pcp/bzo/bar/mtd/tca/amp,biosign Doa 10, Biosign Met/opi/coc/.
Device ID | K983501 |
510k 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/ |
Classification | High Pressure Liquid Chromatography, Methamphetamine |
Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
Contact | Jemo Kang |
Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
Product Code | LAG |
Subsequent Product Code | DIO |
Subsequent Product Code | DIS |
Subsequent Product Code | DJG |
Subsequent Product Code | DJR |
Subsequent Product Code | DKE |
Subsequent Product Code | DKN |
Subsequent Product Code | DKZ |
Subsequent Product Code | LCM |
Subsequent Product Code | LFI |
CFR Regulation Number | 862.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-06 |
Decision Date | 1998-12-18 |