The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign(tm) Amp, Doa-amp, Accusign(tm) Amp-doa-amp, Biosign(tm) Amp, Doa-amp.
| Device ID | K945610 |
| 510k Number | K945610 |
| Device Name: | ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-15 |
| Decision Date | 1995-04-13 |