The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Status Cup Accusign Cup.
| Device ID | K991751 |
| 510k Number | K991751 |
| Device Name: | STATUS CUP ACCUSIGN CUP |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| 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 | DKE |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LAG |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-24 |
| Decision Date | 1999-06-18 |