The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Angiotensin Converting Enzyme 305-uv.
| Device ID | K854245 |
| 510k Number | K854245 |
| Device Name: | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV |
| Classification | Radioassay, Angiotensin Converting Enzyme |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Quincy E Crider |
| Correspondent | Quincy E Crider SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KQN |
| CFR Regulation Number | 862.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1986-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746014 | K854245 | 000 |