The following data is part of a premarket notification filed by Agen Biomedical Ltd. with the FDA for Simplify D-dimer, Model Dcgk1.
| Device ID | K993276 |
| 510k Number | K993276 |
| Device Name: | SIMPLIFY D-DIMER, MODEL DCGK1 |
| Classification | Fibrin Split Products |
| Applicant | AGEN BIOMEDICAL LTD. 7 & 11 DURBELL ST., ACACIA RIDGE Brisbane, Queensland, AU 4110 |
| Contact | Russel Richards |
| Correspondent | Russel Richards AGEN BIOMEDICAL LTD. 7 & 11 DURBELL ST., ACACIA RIDGE Brisbane, Queensland, AU 4110 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-30 |
| Decision Date | 1999-12-14 |