510(k) DEN140001
- Device
- ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
- Applicant
- Kronus Market Development Associates, Inc.
- 510(k) number
- DEN140001
- Product code
- PHF
- Decision
- Unknown (DENG)
- Decision date
- 2014-08-20
- Date received
- 2014-06-16
- Regulation
- 866.5670
- Classification name
- Zinc Transporter 8 Auto-Antibody
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- TANIS JIMENEZ
- Address
- 170 S. Seneca Springs Way Suite 105 Star ID US 83669 83669
FDA Registration Numbers#
- 3003834021
- 2025560
Source Documents#
510(k) summary PDF not indicated by FDA