The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Cardiolipin G Eia Test System.
| Device ID | K946215 |
| 510k Number | K946215 |
| Device Name: | CARDIOLIPIN G EIA TEST SYSTEM |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Edward C Wilson |
| Correspondent | Edward C Wilson HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-21 |
| Decision Date | 1996-01-24 |