TOTAL T3 CHEMILUMINESCENCE ASSAY— 510(k) K923015
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K923015 for TOTAL T3 CHEMILUMINESCENCE ASSAY, Substantially Equivalent on 1992-09-02. Applicant: Nichols Institute Diagnostics. Device class: 2.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code CDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.1710
- 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 CDP
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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
Adverse events under product code CDP
product code CDP- Malfunction
- 647
- Total
- 647
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.