510(k) K242613
- Device
- NxTAG® Respiratory Pathogen Panel
- Applicant
- Luminex Molecular Diagnostics, Inc.
- 510(k) number
- K242613
- Product code
- OCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-02
- Date received
- 2024-09-03
- Regulation
- 866.3980
- Classification name
- Respiratory Virus Panel Nucleic Acid Assay System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Tara Vivian
- Address
- 439 University Ave. Toronto CA M5G 1Y8 M5G 1Y8
FDA Registration Numbers
- 9610126
- 3010749841
- 3013019728
- 3009613136
- 2243471
- 1528450
- 3029059580
- 3008632402
- 3003018722
- 1221359
- 3004530258
- 3019946577
- 2023365
- 3012494290
- 2024800
- 3003795116
- 3023372670
- 3005360469
- 3010770794
- 3006028115
- 9681630
- 3021140368
- 1650733
- 3002777243
- 3007799234
- 3003030793
- 3005248192
- 3002773840
- 3006198300
- 3016838963
- 3038610665
- 3004141078
Source Documents
510(k) summary PDF not indicated by FDA
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