NICHOLS ADVANTAGE CORTISOL— 510(k) K042689
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K042689 for NICHOLS ADVANTAGE CORTISOL, Substantially Equivalent on 2004-12-09. Applicant: Nichols Institute Diagnostics. Device class: 2.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code CGR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
Recent devices under product code CGR
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- K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
- K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
- K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
Data sourced from openFDA. This site is unofficial and independent of the FDA.