DeviceClearance

SOFIA (R) STREP A+ FIA— 510(k) K141775

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K141775 for SOFIA (R) STREP A+ FIA, Substantially Equivalent on 2014-12-16. 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
Download summary PDFView on FDA.gov ↗

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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 →

Recalls naming K141775

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141775.

Data sourced from openFDA. This site is unofficial and independent of the FDA.