SR1 FREE T4 ENZYME IMMUNOASSAY— 510(k) K912937
Substantially EquivalentSerono-Baker Diagnostics, Inc.
FDA 510(k) clearance K912937 for SR1 FREE T4 ENZYME IMMUNOASSAY, Substantially Equivalent on 1991-11-19. Applicant: Serono-Baker Diagnostics, Inc..
Clearance details
- Applicant
- Serono-Baker Diagnostics, Inc.
- Product code
- Code CEC
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allentown, PA, 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.