NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT— 510(k) K962408
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K962408 for NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT, Substantially Equivalent on 1997-03-18. Applicant: Nichols Institute Diagnostics.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code CEC
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
Adverse events under product code CEC
product code CEC- Malfunction
- 899
- Total
- 899
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.