Panels › Immunology › Product code DDZ · Class 2
Albumin, Fitc, Antigen, Antiserum, Control
Regulation 866.5040
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DDZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Randox Laboratories, Ltd. | 1 | 1 |
| Dako Corp. | 1 | 0 |
| Good Biotech Corp. | 1 | 0 |
| Pointe Scientific, Inc., | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2024 | Randox Laboratories Ltd. Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay
Catalog Number: MA2426 Open, Classified |
DDZ | K002674 |
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