ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
FDA 510(k) clearance K092705 · decided 2010-05-28
Clearance details
- K-number
- K092705
- Device name
- ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
- Applicant
- Abbott Molecular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-03
- Decision date
- 2010-05-28
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- OOI
- Device class
- 2
- Regulation number
- 862.2570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Molecular
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 |
| QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (K123955) | Life Technologies Corporation | 2013-03-08 |
| ROTOR-GENE Q MDX (K113319) | QIAGEN GmbH | 2012-02-06 |
| 3M INTEGRATED CYCLER (110V) & (220V) (K102314) | Focus Diagnostics, Inc. | 2010-10-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Abbott m2000sp is an automated system for performing sample preparation for nucleic ac recall (Z-0948-2015) | Abbott Molecular | 2015-01-09 |
| Abbott m2000sp, an automated system for performing sample preparation for nucleic acid tes recall (Z-0463-2015) | Abbott Molecular | 2014-11-25 |
| 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System) recall (Z-2169-2014) | Abbott Molecular | 2014-08-08 |
| Abbott m2000sp Instrument; an automated fluid handling system for performing sample prepar recall (Z-0634-2013) | Abbott Molecular | 2013-01-03 |
| Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code S recall (Z-2013-2012) | Abbott Molecular | 2012-07-14 |
| Abbott m2000sp Instrument; an automated system for performing sample preparation for nucle recall (Z-0365-2012) | Abbott Molecular | 2012-01-11 |
| Abbott m2000rt System software; an automated system for performing fluorescence-based PCR recall (Z-0048-2012) | Abbott Molecular | 2011-10-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Alinity m HR HPV (P230003/S009) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HBV (P200013/S027) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HR HPV (P230003/S008) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HBV (P200013/S026) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HR HPV (P230003/S006) | Abbott Molecular, Inc. | 2025-09-10 |
| Vysis CLL Fish Probe Kit (P150041/S007) | Abbott Molecular, Inc. | 2025-08-08 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S022) | Abbott Molecular, Inc. | 2025-08-05 |
| Alinity m HR HPV (P230003/S007) | Abbott Molecular, Inc. | 2025-04-18 |