The following data is part of a premarket notification filed by Medica Corp. with the FDA for Medica Ii-f-asma Test Kit.
| Device ID | K790430 |
| 510k Number | K790430 |
| Device Name: | MEDICA II-F-ASMA TEST KIT |
| Classification | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | MEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBE |
| CFR Regulation Number | 866.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-02 |
| Decision Date | 1979-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545027025 | K790430 | 000 |
| 00813545027018 | K790430 | 000 |
| 00813545026677 | K790430 | 000 |
| 00813545026660 | K790430 | 000 |
| 00813545026653 | K790430 | 000 |
| 00813545026646 | K790430 | 000 |