QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
FDA 510(k) clearance K123955 · decided 2013-03-08
Clearance details
- K-number
- K123955
- Device name
- QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
- Applicant
- Life Technologies Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-12-21
- Decision date
- 2013-03-08
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- OOI
- 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
+ Add to Predicate Builder ◉ Watch Life Technologies Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Revogene (K243922) | Meridian Bioscience, Inc. | 2025-03-20 |
| Revogene (K222779) | Meridian Bioscience, Inc. | 2023-01-26 |
| Revogene (K220480) | Meridian Bioscience, Inc. | 2022-07-11 |
| revogene (K170558) | Genepoc, Inc. | 2017-05-25 |
| ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) (K161495) | Luminex Corporation | 2016-06-30 |
| ARIES System (K160517) | Luminex Corporation | 2016-04-12 |
| ARIES System (K151917) | Luminex Corporation | 2015-10-06 |
| Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (K151690) | Alere Scarborough, Inc. | 2015-07-16 |
| BD VIPER LT SYSTEM (K140447) | Becton, Dickinson and Company | 2014-05-20 |
| ROTOR-GENE Q MDX (K113319) | QIAGEN GmbH | 2012-02-06 |
| 3M INTEGRATED CYCLER (110V) & (220V) (K102314) | Focus Diagnostics, Inc. | 2010-10-29 |
| NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG (K093383) | bioMerieux, Inc. | 2010-07-06 |
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 |