NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY— 510(k) K033727
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K033727 for NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY, Substantially Equivalent on 2004-04-22. Applicant: Nichols Institute Diagnostics. Device class: 2.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code CEW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1545
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
Recent devices under product code CEW
view allMore 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
- K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
Adverse events under product code CEW
product code CEW- Malfunction
- 480
- Total
- 480
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.