The following data is part of a premarket notification filed by Agen Biomedical Ltd. with the FDA for Bed Red D-dimer Whole Blood Agglutination Assay.
| Device ID | K905643 |
| 510k Number | K905643 |
| Device Name: | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY |
| Classification | Fibrin Split Products |
| Applicant | AGEN BIOMEDICAL LTD. 11 DURBELL ST., ACACIA RIDGE Brisbane, AU 4110 |
| Contact | Robert Herrington |
| Correspondent | Robert Herrington AGEN BIOMEDICAL LTD. 11 DURBELL ST., ACACIA RIDGE Brisbane, 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 | 1990-12-17 |
| Decision Date | 1991-04-12 |