FDA Product Code
FDA Product Code PCG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | Kronus, Inc. | 2018-11-23 | Traditional | PDF ↗ |
| K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | Kronus Market Development Associates, Inc. | 2012-12-20 | Traditional | PDF ↗ |
Product code PCG · Class II · Immunology. Data: openFDA.