The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-cardiolipin Antibody (igm-aca) Test.
| Device ID | K933788 |
| 510k Number | K933788 |
| Device Name: | ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Susan Krasny |
| Correspondent | Susan Krasny 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 | 1993-08-04 |
| Decision Date | 1995-03-07 |