NEOSCREEN ELISA TSH— 510(k) K942658
Substantially EquivalentPantex, Div. Bio-Analysis, Inc.
FDA 510(k) clearance K942658 for NEOSCREEN ELISA TSH, Substantially Equivalent on 1995-02-24. Applicant: Pantex, Div. Bio-Analysis, Inc..
Clearance details
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
- Product code
- Code JLW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Adverse 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.