Atlas FDA

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k) clearance K241806 · decided 2025-01-08

Clearance details

K-number
K241806
Device name
Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
Applicant
Life Technologies Corporation
Decision
Substantially Equivalent
Date received
2024-06-21
Decision date
2025-01-08
Days to decision
201 days
Clearance type
Traditional
Product code
QOF
Device class
2
Regulation number
866.3981
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Pleasanton,, CA, US
Third-party review
No
Expedited review
No

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cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455)Roche Molecular Systems, Inc.2025-07-31
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cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (K243400)Roche Molecular Systems, Inc.2025-04-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Oncomine™ Dx Target Test (P160045/S051)Life Technologies Corporation2025-11-21
Oncomine Dx Target Test (P160045/S050)Life Technologies Corporation2025-11-19
Oncomine Dx Express Test (P240040/S003)Life Technologies Corporation2025-10-22
Oncomine Dx Express Test (P240040/S002)Life Technologies Corporation2025-10-15
Oncomine Dx Target Test (P160045/S049)Life Technologies Corporation2025-08-08
Oncomine™ Dx Express Test (P240040/S001)Life Technologies Corporation2025-08-07
Oncomine Dx Express Test (P240040)Life Technologies Corporation2025-07-02
Oncomine Dx Target Test (P160045/S046)Life Technologies Corporation2024-10-17