STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
FDA 510(k) clearance K121046 · decided 2012-12-20
Clearance details
- K-number
- K121046
- Device name
- STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
- Applicant
- Kronus Market Development Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-06
- Decision date
- 2012-12-20
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- PCG
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Star, ID, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit (K180607) | Kronus, Inc. | 2018-11-23 |
Recalls involving this device
No recalls on record reference this clearance.