TRIAGE STATMETER— 510(k) K973547
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K973547 for TRIAGE STATMETER, Substantially Equivalent on 1998-01-13. Applicant: Biosite Incorporated.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code KHO
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code KHO
product code KHO- Malfunction
- 1,339
- Total
- 1,339
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.