The following data is part of a premarket notification filed by Medica Corp. with the FDA for Medica Iif Anti-skin Antibody Test Kit.
| Device ID | K902237 |
| 510k Number | K902237 |
| Device Name: | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | MEDICA CORP. 2382 CAMINO VIDA ROBLE, STE. I Carlsbad, CA 92009 |
| Contact | Bartl, Ph.d. |
| Correspondent | Bartl, Ph.d. MEDICA CORP. 2382 CAMINO VIDA ROBLE, STE. I Carlsbad, CA 92009 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-18 |
| Decision Date | 1990-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545027131 | K902237 | 000 |
| 00813545027124 | K902237 | 000 |
| 00813545026691 | K902237 | 000 |
| 00813545026684 | K902237 | 000 |