FDA Product Code
FDA Product Code DDZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5040
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | Good Biotech Corp. | 2005-04-21 | Traditional | PDF ↗ |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | Pointe Scientific, Inc., | 2003-04-28 | Traditional | PDF ↗ |
| K002674 | RANDOX MICROALBUMIN | Randox Laboratories, Ltd. | 2000-10-05 | Traditional | PDF ↗ |
| K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | Dako Corp. | 1983-07-18 | Traditional | PDF ↗ |
Product code DDZ · Class II · Immunology. Data: openFDA.