The following data is part of a premarket notification filed by Thermo Electron Corporation with the FDA for Thermo Electron Angiotensin Converting Enzyme Infinity (ace) Reagent.
| Device ID | K041657 |
| 510k Number | K041657 |
| Device Name: | THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT |
| Classification | Radioassay, Angiotensin Converting Enzyme |
| Applicant | THERMO ELECTRON CORPORATION 331 SOUTH 104TH STREET Louisville, CO 80027 |
| Contact | Bola Nicholson |
| Correspondent | Bola Nicholson THERMO ELECTRON CORPORATION 331 SOUTH 104TH STREET Louisville, CO 80027 |
| Product Code | KQN |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-18 |
| Decision Date | 2004-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275003444 | K041657 | 000 |
| 00845275003420 | K041657 | 000 |