FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
K Number: K152013
·
Decision Apr 11, 2016
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
7
Applicant Total
138
Review Days
265
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Basic Information
- Device Name
- QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
- K Number
- K152013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- July 21, 2015
- Decision Date
- April 11, 2016
- Product Code
- LSW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LSW | Anti-Dna Antibody, Antigen And Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LSW), ordered by most recent decision date.
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO AESKULISA DS DNA G
FDA 510(k)
FDA Class 2
·Immunology
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
FDA 510(k)
FDA Class 2
·Immunology
FIDIS DSDNA
FDA 510(k)
FDA Class 2
·Immunology
AESKULISA DS DNA G
FDA 510(k)
FDA Class 2
·Immunology
ANTI-DSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Inova Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K213403 | Aptiva CTD Essential Reagent | Sep 29, 2023 | Substantially Equivalent |
| K200230 | Aptiva Celiac Disease IgG Reagent | Aug 26, 2021 | Substantially Equivalent |
| K193604 | Aptiva Celiac Disease IgA Reagent | Jun 16, 2021 | Substantially Equivalent |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Dec 11, 2020 | Substantially Equivalent |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Apr 17, 2019 | Substantially Equivalent |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Oct 16, 2018 | Substantially Equivalent |
| K180975 | QUANTA Flash HMGCR Reagents | Jun 25, 2018 | Substantially Equivalent |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | Dec 22, 2017 | Substantially Equivalent |