FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
K Number: K170993
·
Decision Dec 22, 2017
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
138
Review Days
263
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Basic Information
- Device Name
- QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
- K Number
- K170993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5180
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- April 3, 2017
- Decision Date
- December 22, 2017
- Product Code
- NXO
- 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 |
|---|---|---|---|
| NXO | Calprotectin, Fecal | FDA class 2 | Immunology |
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| 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 |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Sep 6, 2017 | Substantially Equivalent |