The following data is part of a premarket notification filed by Cytotech, Inc. with the FDA for Cytotech Cic Enzyme Immunoassay.
| Device ID | K862649 |
| 510k Number | K862649 |
| Device Name: | CYTOTECH CIC ENZYME IMMUNOASSAY |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Contact | Bryan L Kiehl |
| Correspondent | Bryan L Kiehl CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-11 |
| Decision Date | 1986-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613335535 | K862649 | 000 |