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 | K981801 |
| 510k Number | K981801 |
| Device Name: | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA |
| Classification | U.v. Spectrometry, Tricyclic Antidepressant Drugs |
| 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 | LFH |
| Subsequent Product Code | LFG |
| Subsequent Product Code | LFI |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-08-25 |