QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)— 510(k) K945080

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K945080 for QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS), Substantially Equivalent on 1995-02-10. Applicant: Quidel Corp..

Clearance details

Applicant: Quidel Corp.
Product code: Code GTY
Advisory panel: Microbiology
Date received: 1994-10-17
Decision date: 1995-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.