510(k) K161495
- Device
- ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton Of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
- Applicant
- LUMINEX CORPORATION
- 510(k) number
- K161495
- Product code
- OOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-30
- Date received
- 2016-06-01
- Regulation
- 862.2570
- Classification name
- Real Time Nucleic Acid Amplification System
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTIE HUGHES
- Address
- 12212 Technology Blvd. Austin TX US 78727 78727
FDA Registration Numbers#
- 3004141078
- 8043379
- 3014325803
- 3016838963
- 3004013603
- 1550222
- 3014661462
- 3003083993
- 3016837106
- 3004530258
- 3009972873
- 3008494306
- 1119779
- 3016635427
- 3012449645
- 3022977716
- 3023372670
- 3008754394
- 3003795116
- 3025430789
- 3006028115
- 3011461582
- 2243471
- 3003537036
- 3008318433
- 3043138885
- 3017644086
- 1650733
- 3007867838
- 3012918440
- 1221359
- 3007923088
- 3009613136
- 3009155756
- 1528450
- 3026886124
- 3005748784
- 3006198300
- 3003402518
- 3003540236
- 3012494290
- 9610240
- 3019946577
- 3003018722
- 2024674
- 3012259842
- 2023365
- 3016619649
- 3003673482
- 9610126
- 3043088937
- 3007420875
- 3008517993
- 3005248192
- 3011781554
- 3009297077
- 2024800
- 3004061467
- 3019837962
- 3002777243
- 3020925311
- 3005748564
- 3027645317
- 3009875001
- 3009984016
- 3009609218
- 3002773840
- 3007799234
- 3016548670
- 3024647994
- 3029059580
- 3026940910
- 3012598266
- 3003366417
- 3042971506
- 3003030793
- 3005118020
- 1524213
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OOI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243922 | Revogene | Meridian Bioscience, Inc. | 2025-03-20 |
| K222779 | Revogene | Meridian Bioscience, Inc. | 2023-01-26 |
| K220480 | Revogene | Meridian Bioscience, Inc. | 2022-07-11 |
| K170558 | revogene | Genepoc, Inc. | 2017-05-25 |
| K160517 | ARIES System | Luminex Corporation | 2016-04-12 |
| K151917 | ARIES System | Luminex Corporation | 2015-10-06 |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015-07-16 |
| K140447 | BD VIPER LT SYSTEM | Becton, Dickinson and Company | 2014-05-20 |
| K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | Life Technologies Corporation | 2013-03-08 |
| K113319 | ROTOR-GENE Q MDX | QIAGEN GmbH | 2012-02-06 |
| K102314 | 3M INTEGRATED CYCLER (110V) & (220V) | Focus Diagnostics, Inc. | 2010-10-29 |
| K093383 | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG | bioMerieux, Inc. | 2010-07-06 |
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | Abbott Molecular, Inc. | 2010-05-28 |
Legacy Summary#
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FDA Review#
Decision Summary