The following data is part of a premarket notification filed by Agen Biomedical Ltd. with the FDA for Agen Dimertest Eia.
| Device ID | K890189 |
| 510k Number | K890189 |
| Device Name: | AGEN DIMERTEST EIA |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | AGEN BIOMEDICAL LTD. 90 EAST HALSEY RD. Parsippany, NJ 07054 |
| Contact | Mark Morrisson |
| Correspondent | Mark Morrisson AGEN BIOMEDICAL LTD. 90 EAST HALSEY RD. Parsippany, NJ 07054 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-17 |
| Decision Date | 1989-03-03 |