Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit— 510(k) K180607
Substantially EquivalentKronus, Inc.
FDA 510(k) clearance K180607 for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit, Substantially Equivalent on 2018-11-23. Applicant: Kronus, Inc.. Device class: 2.
Clearance details
- Applicant
- Kronus, Inc.
- Product code
- Code PCG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Star, ID, US
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