Sofia Strep A+ FIA, Sofia 2 Analyzer— 510(k) K171976
Substantially EquivalentQuidel Corporation
FDA 510(k) clearance K171976 for Sofia Strep A+ FIA, Sofia 2 Analyzer, Substantially Equivalent on 2017-12-21. Applicant: Quidel Corporation. Device class: 1.
Clearance details
- Applicant
- Quidel Corporation
- Product code
- Code GTY
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- San Diego,, CA, US
Recent devices under product code GTY
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- K230349 — Lyra RSV+hMPV Assay
- DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
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.