The following data is part of a premarket notification filed by Medica, Inc. with the FDA for Medica Indirect Immunofluorescence (iif) Anti- Endomysial Antibody (aema) Test Kit, Model 6001-esd.
| Device ID | K993034 |
| 510k Number | K993034 |
| Device Name: | MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | MEDICA, INC. 336 ENCINITAS BLVD., SUITE 200 Encinitas, CA 92024 |
| Contact | Rhodora Chapoco |
| Correspondent | Rhodora Chapoco MEDICA, INC. 336 ENCINITAS BLVD., SUITE 200 Encinitas, CA 92024 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-09 |
| Decision Date | 1999-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545027216 | K993034 | 000 |
| 00813545027117 | K993034 | 000 |
| 00813545027100 | K993034 | 000 |
| 00813545027094 | K993034 | 000 |
| 00813545027087 | K993034 | 000 |
| 00813545027070 | K993034 | 000 |
| 00813545026714 | K993034 | 000 |
| 00813545026707 | K993034 | 000 |