The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Angiotensin Converting Enzyme Rea.
| Device ID | K942497 |
| 510k Number | K942497 |
| Device Name: | ANGIOTENSIN CONVERTING ENZYME REA |
| Classification | Radioassay, Angiotensin Converting Enzyme |
| 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 | KQN |
| CFR Regulation Number | 862.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-17 |
| Decision Date | 1994-11-15 |