WONDFO RAPID STREP A TEST— 510(k) K133343
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K133343 for WONDFO RAPID STREP A TEST, Substantially Equivalent on 2014-01-31. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- 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
- Gaithersburg, MD, US
Recent devices under product code GTY
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- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
- K251289 — WELLlife COVID-19 Antigen Test Rx
- K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette) +3 more
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.