Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Life Technologies Corporation · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

142 daysmedian FDA review time
309 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241806Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV SelLife Technologies Corporation2025-01-082010
K233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies Corporation2024-07-102640
K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied BioLife Technologies Corporation2020-02-213090
K170299Ion PGM Dx SystemLife Technologies Corporation2017-06-221420
K123955QUANTSTUDIO DX REAL-TIME PCR INSTRUMENTLife Technologies Corporation2013-03-08770
K103302STEMPRO MSC SFMLife Technologies Corporation2011-02-181010
K100616KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828,Life Technologies Corporation2010-05-20770

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda