The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Micro-albumin Eia Assay.
| Device ID | K970932 |
| 510k Number | K970932 |
| Device Name: | ORGENTEC MICRO-ALBUMIN EIA ASSAY |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard Conley |
| Correspondent | Richard Conley AMERICAN LABORATORY PRODUCTS CO., LTD. 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 | 1997-02-20 |
| Decision Date | 1997-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00404847438819 | K970932 | 000 |
| 04048474038811 | K970932 | 000 |
| 00840239038814 | K970932 | 000 |