The following data is part of a premarket notification filed by Medica Corp. with the FDA for Test Kit, Iif-ana.
| Device ID | K782048 |
| 510k Number | K782048 |
| Device Name: | TEST KIT, IIF-ANA |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | MEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-08 |
| Decision Date | 1979-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545026578 | K782048 | 000 |
| 00813545026561 | K782048 | 000 |