DDZ — Albumin, Fitc, Antigen, Antiserum, Control Class II
FDA product code DDZ covers "Albumin, Fitc, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5040. Submissions are reviewed by the Immunology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DDZ
- Device Class
- Class II
- Regulation Number
- 866.5040
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050576 | good biotech | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | April 21, 2005 |
| K023860 | pointe scientific, inc | MICROALBUMIN REAGENT SET AND CALIBRATORS | April 28, 2003 |
| K002674 | randox laboratories | RANDOX MICROALBUMIN | October 5, 2000 |
| K831902 | dako | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | July 18, 1983 |