The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-cardiolipin Antibody (aca) Screen Elisa.
| Device ID | K970177 |
| 510k Number | K970177 |
| Device Name: | ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Richard E Greco, R.a.c. |
| Correspondent | Richard E Greco, R.a.c. IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-17 |
| Decision Date | 1997-06-11 |