The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Mardx Mitochondria Eia Test System.
| Device ID | K950110 |
| 510k Number | K950110 |
| Device Name: | MARDX MITOCHONDRIA EIA TEST SYSTEM |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Patricia B Shrader |
| Correspondent | Patricia B Shrader HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-11 |
| Decision Date | 1995-05-15 |