The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Anticardiolipin Antibody Test System.
| Device ID | K903531 |
| 510k Number | K903531 |
| Device Name: | ANTICARDIOLIPIN ANTIBODY TEST SYSTEM |
| Classification | Activated Partial Thromboplastin |
| Applicant | MEDICAL INNOVATIONS CORP. P.O. BOX 18225 Portland, OR 97218 |
| Contact | Metcalf, Ph.d. |
| Correspondent | Metcalf, Ph.d. MEDICAL INNOVATIONS CORP. P.O. BOX 18225 Portland, OR 97218 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-06 |
| Decision Date | 1991-01-25 |