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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2005 | K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H Good Biotech Corp., TW | DDZ |
| Apr 28, 2003 | K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS Pointe Scientific, Inc., | DDZ |
| Oct 5, 2000 | K002674 | RANDOX MICROALBUMIN Randox Laboratories, Ltd., IE | DDZ |
| Jul 18, 1983 | K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- Dako Corp. | DDZ |
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