Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
FDA 510(k) clearance K191030 · decided 2020-02-21
Clearance details
- K-number
- K191030
- Device name
- Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
- Applicant
- Life Technologies Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-04-18
- Decision date
- 2020-02-21
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- PCA
- Device class
- 2
- Regulation number
- 862.2570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |