The following data is part of a premarket notification filed by Orgentec with the FDA for Orgentec Micro-albumin Pin Eia Assay.
| Device ID | K960274 |
| 510k Number | K960274 |
| Device Name: | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | ORGENTEC P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard Conley |
| Correspondent | Richard Conley ORGENTEC P.O. BOX 451 Windham, NH 03087 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-19 |
| Decision Date | 1996-03-29 |