Source document or public record
FDA 510(k) K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
FDA 510(k) index record K233453. Device: Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit. Applicant as listed: Life Technologies Corporation. Decision date: 2024-07-10.
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"device_name": "Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit"
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K233453.
Device name: Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit. Applicant as listed: Life Technologies Corporation.
Decision date: 2024-07-10. Decision wording: Substantially Equivalent.
Product code: QQX. Regulation: 21 CFR 866.3981. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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