The following data is part of a premarket notification filed by Cytotech, Inc. with the FDA for Cytotech C1-inhibitor Enzyme Immunoassay.
| Device ID | K872426 |
| 510k Number | K872426 |
| Device Name: | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Contact | Kiehl, Phd |
| Correspondent | Kiehl, Phd CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Product Code | DBA |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-22 |
| Decision Date | 1987-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613335580 | K872426 | 000 |