The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/opi/coc/thc/pcp/bzo/bar/mtd/tca/amp, Biosign Doa10, Biosign Met/opi/.
| Device ID | K990786 |
| 510k Number | K990786 |
| Device Name: | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ |
| Classification | High Pressure Liquid Chromatography, Methamphetamine |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-10 |
| Decision Date | 1999-03-26 |