Ion PGM Dx System
FDA 510(k) clearance K170299 · decided 2017-06-22
Clearance details
- K-number
- K170299
- Device name
- Ion PGM Dx System
- Applicant
- Life Technologies Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-01-31
- Decision date
- 2017-06-22
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- PFF
- Device class
- 2
- Regulation number
- 862.2265
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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| ILLUMINA MISEQDX PLATFORM (DEN130011) | Illumina, Inc. | 2013-11-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oncomine Dx Target Test (P160045/S051) | Life Technologies Corporation | 2025-11-21 |
| Oncomine Dx Target Test (P160045/S050) | Life Technologies Corporation | 2025-11-19 |
| Oncomine Dx Express Test (P240040/S003) | Life Technologies Corporation | 2025-10-22 |
| Oncomine Dx Express Test (P240040/S002) | Life Technologies Corporation | 2025-10-15 |
| Oncomine Dx Target Test (P160045/S049) | Life Technologies Corporation | 2025-08-08 |
| Oncomine Dx Express Test (P240040/S001) | Life Technologies Corporation | 2025-08-07 |
| Oncomine Dx Express Test (P240040) | Life Technologies Corporation | 2025-07-02 |
| Oncomine Dx Target Test (P160045/S046) | Life Technologies Corporation | 2024-10-17 |