The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa8, Doa8 Panel, Thc/opi/coc/amp/bzo/bar/tca/pcp, Biosign Doa8, Thc/opi/coc/amp/bzo/bar/tca/pap, Status Ds Do8.
| Device ID | K991078 |
| 510k Number | K991078 |
| Device Name: | ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
| Product Code | DKE |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKN |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LFI |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-26 |
| Decision Date | 1999-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10743816000457 | K991078 | 000 |
| 10743816000440 | K991078 | 000 |
| 10743816000433 | K991078 | 000 |