The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Sera For Antinuclear Antibodies.
| Device ID | K820945 |
| 510k Number | K820945 |
| Device Name: | SERA FOR ANTINUCLEAR ANTIBODIES |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-06 |
| Decision Date | 1982-10-26 |