The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 2, Accusign Doa, Accusign Bar/bzo, Biosign Doa 2, Biosign Bar/bzo, First Check Panel 2 Bar/bzo, Status Ds B.
| Device ID | K974181 |
| 510k Number | K974181 |
| Device Name: | ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| 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 | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-06 |
| Decision Date | 1997-12-11 |