The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Status Stik, Accusign Stik.
| Device ID | K992068 |
| 510k Number | K992068 |
| Device Name: | STATUS STIK, ACCUSIGN STIK |
| 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 | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-18 |
| Decision Date | 1999-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10743816001386 | K992068 | 000 |
| 10743816001379 | K992068 | 000 |
| 10743816000341 | K992068 | 000 |
| 10743816000334 | K992068 | 000 |