The following data is part of a premarket notification filed by Agen Biomedical Ltd. with the FDA for Dimertest(r) Latex.
| Device ID | K882944 |
| 510k Number | K882944 |
| Device Name: | DIMERTEST(R) LATEX |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | AGEN BIOMEDICAL LTD. 11 DURBELL ST., ACACIA RIDGE Brisbane, AU 4110 |
| Contact | Russell Richards |
| Correspondent | Russell Richards AGEN BIOMEDICAL LTD. 11 DURBELL ST., ACACIA RIDGE Brisbane, AU 4110 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-14 |
| Decision Date | 1988-08-17 |