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 |