510(k) clearance
Oncomine ™ Dx Express Test
- 510(k) number
- K260827
- Applicant
- Life Technologies Corporation
- Decision date
- Oct 15, 2026
- Date received
- Mar 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SBY
- Device type
- High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
- Device class
- Class II
- Regulation
- 21 CFR 866.6085
- Advisory committee
- Pathology
- Statement or summary
- Summary
- Third party
- N
- Location
- Frederick, MD, US