FDA 510(k) clearance · back to tracker
Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
Life Technologies Corporation cleared K233453 on 2024-07-10, decision: substantially equivalent
K-number
K233453
Sponsor
Life Technologies Corporation
Device
Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
Class
Class II
Decision
Substantially Equivalent
Decision date
2024-07-10
Product code
QQX
Advisory committee
Microbiology
Medical specialty
Microbiology
Regulation number
866.3981
Official FDA record
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FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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