VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY— 510(k) K921816
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K921816 for VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY, Substantially Equivalent on 1992-06-18. Applicant: Biomerieux Vitek, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
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More clearances from Biomerieux Vitek, Inc.
view allAdverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
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.