FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Somatic Gene Mutation Detection System
PMA: P140023
·
Supplement: S031
·
Decision Dec 31, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Somatic Gene Mutation Detection System
- Trade Name
- cobas® KRAS Mutation Test
- PMA Number
- P140023
- Supplement Number
- S031
- Device Class
- FDA Class 3
- Product Code
- OWD
- Generic Name
- Somatic gene mutation detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 31, 2025
- Date Received
- December 2, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
changes to QC testing of filters used in reagent manufacturing
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | FDA class 3 | Unknown |