QTEST(R) STREP— 510(k) K935667
Substantially EquivalentBecton Dickinson Advanced Diagnostics
FDA 510(k) clearance K935667 for QTEST(R) STREP, Substantially Equivalent on 1994-04-21. Applicant: Becton Dickinson Advanced Diagnostics.
Clearance details
- Applicant
- Becton Dickinson Advanced Diagnostics
- Product code
- Code GTY
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Adverse events under product code GTY
product code GTY- Death
- 2
- Total
- 2
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.