QUICKVUE DIPSTICK STREP A— 510(k) K011097
Substantially EquivalentQuidel Corp.
FDA 510(k) clearance K011097 for QUICKVUE DIPSTICK STREP A, Substantially Equivalent on 2001-05-08. Applicant: Quidel Corp.. Device class: 1.
Clearance details
- Applicant
- Quidel Corp.
- 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
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code GTY
view allMore clearances from Quidel Corp.
view allAdverse 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 →
Recalls naming K011097
K-number listed on FDA's recall record- Z-2169-2026 — QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
- Z-2545-2025 — QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011097.
Data sourced from openFDA. This site is unofficial and independent of the FDA.