MMH PTH RIA KIT— 510(k) K830700
Substantially EquivalentDiagnostic Systems
FDA 510(k) clearance K830700 for MMH PTH RIA KIT, Substantially Equivalent on 1983-04-06. Applicant: Diagnostic Systems.
Clearance details
- Applicant
- Diagnostic Systems
- Product code
- Code CEW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code CEW
product code CEW- Malfunction
- 480
- Total
- 480
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.