The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/opi/coc/amp/bzo/bar/tca/pcp, Biosign Doa 8, Biosign Thc/opi/coc/amp/p.
| Device ID | K983147 |
| 510k Number | K983147 |
| Device Name: | ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| 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 | 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768001321 | K983147 | 000 |