The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Cardiolipin Antibody Kit (eia Method0.
| Device ID | K932373 |
| 510k Number | K932373 |
| Device Name: | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
| Contact | Charles A Willand |
| Correspondent | Charles A Willand HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-17 |
| Decision Date | 1993-07-16 |