The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Tca, Biosign Tca, Staus Ds Tca.
| Device ID | K980249 |
| 510k Number | K980249 |
| Device Name: | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| 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 | LFG |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1998-03-13 |