The following data is part of a premarket notification filed by Medica Corp. with the FDA for Iif-apca Test Kit.
| Device ID | K790759 |
| 510k Number | K790759 |
| Device Name: | IIF-APCA TEST KIT |
| Classification | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | MEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBJ |
| CFR Regulation Number | 866.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-17 |
| Decision Date | 1979-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545027063 | K790759 | 000 |
| 00813545027056 | K790759 | 000 |
| 00813545027049 | K790759 | 000 |
| 00813545027032 | K790759 | 000 |