510(k) K121046
- Device
- STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
- Applicant
- KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
- 510(k) number
- K121046
- Product code
- PCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-20
- Date received
- 2012-04-06
- Regulation
- 866.5660
- Classification name
- 21-hydroxylase Antibody (21-ohab)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HEATHER VIELE
- Address
- 170 S. Seneca Springs Way Suite 105 Star ID US 83669 83669
FDA Registration Numbers#
- 3003834021
- 3002800697
- 2245285
- 2025560
Source Documents#
Other 510(k) Records For Product Code PCG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | Kronus, Inc. | 2018-11-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary