The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Buehlmann Lab As, Ace Angio Conv Enzyme Kin Assay.
| Device ID | K913091 |
| 510k Number | K913091 |
| Device Name: | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY |
| Classification | Radioassay, Angiotensin Converting Enzyme |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Contact | Janet F Conley |
| Correspondent | Janet F 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 | 1991-07-12 |
| Decision Date | 1991-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBUHKKACKX1 | K913091 | 000 |
| EBUHKKACK41 | K913091 | 000 |
| EBUHKKACK21 | K913091 | 000 |
| EBUHKKACK1 | K913091 | 000 |