The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Alpco/mercodia Insulin Elisa.
| Device ID | K963911 |
| 510k Number | K963911 |
| Device Name: | ALPCO/MERCODIA INSULIN ELISA |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. 87 INDIAN ROCK RD. Windham, NH 03087 |
| Contact | Richard Conley |
| Correspondent | Richard Conley AMERICAN LABORATORY PRODUCTS CO., LTD. 87 INDIAN ROCK RD. Windham, NH 03087 |
| Product Code | CFP |
| CFR Regulation Number | 862.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1996-11-01 |