STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K913236
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K913236 for STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1991-08-16. Applicant: Baxter Healthcare Corp.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code DHA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Adverse events under product code DHA
product code DHA- Malfunction
- 1,242
- Total
- 1,242
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.