510(k) K180607
- Device
- Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
- Applicant
- KRONUS, Inc.
- 510(k) number
- K180607
- Product code
- PCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-23
- Date received
- 2018-03-07
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brian Deis
- Address
- 170 S. Seneca Springs Way Suite 105 Star ID US 83669 83669
FDA Registration Numbers#
- 2245285
- 3003834021
- 2025560
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PCG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | Kronus Market Development Associates, Inc. | 2012-12-20 |
Legacy Summary#
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FDA Review#
Decision Summary