K233453
- 510(k) number
- K233453
- Device name
- Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
- Applicant
- Life Technologies Corporation CA · US
- Product code
- QQX — Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Decision date
- 2024-07-10
- Date received
- 2023-10-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K233453.pdf
Official FDA record: K233453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.