Oncomine Dx Target Test
FDA premarket approval P160045/S037 · decided 2022-09-19
Approval details
- PMA number
- P160045
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Oncomine Dx Target Test
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Life Technologies Corporation
- Date received
- 2022-06-14
- Decision date
- 2022-09-19
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval for the revised DNA and RNA controls (DNA Control v3 and RNA Control v2) for the Oncomine Dx Target Test
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (K241806) | Life Technologies Corporation | 2025-01-08 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (K233453) | Life Technologies Corporation | 2024-07-10 |
| Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (K191030) | Life Technologies Corporation | 2020-02-21 |
| Ion PGM Dx System (K170299) | Life Technologies Corporation | 2017-06-22 |
| QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (K123955) | Life Technologies Corporation | 2013-03-08 |
| STEMPRO MSC SFM (K103302) | Life Technologies Corporation | 2011-02-18 |
| KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616) | Life Technologies Corporation | 2010-05-20 |