The following data is part of a premarket notification filed by Cytotech, Inc. with the FDA for Cytotech Antinuclear Antibody (ana) Ifa Kit.
| Device ID | K871801 |
| 510k Number | K871801 |
| Device Name: | CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, 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 | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-08 |
| Decision Date | 1987-06-09 |