NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)— 510(k) K011128
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K011128 for NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT), Substantially Equivalent on 2001-09-06. Applicant: Nichols Institute Diagnostics. Device class: 2.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code CIB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1085
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
Recent devices under product code CIB
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- K061758 — ACTIVE RENIN IRMA
- K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
More clearances from Nichols Institute Diagnostics
view all- K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
- K042689 — NICHOLS ADVANTAGE CORTISOL
- K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
- K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.