The following data is part of a premarket notification filed by Immuno Probe, Inc. with the FDA for Cardiolipin Igg,m,a Eia Test System.
| Device ID | K951363 |
| 510k Number | K951363 |
| Device Name: | CARDIOLIPIN IGG,M,A EIA TEST SYSTEM |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | IMMUNO PROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Contact | Edward C Wilson |
| Correspondent | Edward C Wilson IMMUNO PROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-24 |
| Decision Date | 1995-10-13 |