The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Bar-rapid One-step Barbiturate Assay.
| Device ID | K962669 |
| 510k Number | K962669 |
| Device Name: | ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang, Ph.d. |
| Correspondent | Jemo Kang, Ph.d. PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-09 |
| Decision Date | 1996-08-15 |