FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
K Number: K093420
·
Decision Aug 26, 2010
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
10
Applicant Total
26
Review Days
296
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Basic Information
- Device Name
- XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
- K Number
- K093420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3360
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Date Received
- November 3, 2009
- Decision Date
- August 26, 2010
- Product Code
- NTI
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NTI | Drug Metabolizing Enzyme Genotyping Systems | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NTI), ordered by most recent decision date.
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xTAG CYP2D6 Kit v3
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XTAG CYP2C19 KIT V3
FDA 510(k)
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SPARTAN RX CYP2C19 TEST SYSTEM
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XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Luminex Molecular Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | Oct 2, 2024 | Substantially Equivalent |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Mar 11, 2024 | Substantially Equivalent |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Dec 11, 2019 | Substantially Equivalent |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Nov 12, 2019 | Substantially Equivalent |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 4, 2019 | Substantially Equivalent |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 30, 2018 | Substantially Equivalent |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 30, 2018 | Substantially Equivalent |
| K170492 | xTAG CYP2D6 Kit v3 | Aug 11, 2017 | Substantially Equivalent |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Dec 15, 2016 | Unknown |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Dec 15, 2016 | Unknown |