TSH - THIRD GENERATION LOW CONTROLS— 510(k) K924675
Substantially EquivalentNichols Institute
FDA 510(k) clearance K924675 for TSH - THIRD GENERATION LOW CONTROLS, Substantially Equivalent on 1992-11-18. Applicant: Nichols Institute. Device class: 1.
Clearance details
- Applicant
- Nichols Institute
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- 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 JJX
view allMore clearances from Nichols Institute
view allAdverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.