FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aptiva CTD Essential Reagent
K Number: K213403
·
Decision Sep 29, 2023
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
138
Review Days
711
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Basic Information
- Device Name
- Aptiva CTD Essential Reagent
- K Number
- K213403
- 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
- October 18, 2021
- Decision Date
- September 29, 2023
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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Other Clearances by Inova Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | Feb 6, 2026 | Substantially Equivalent |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Dec 17, 2024 | 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 |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Sep 6, 2017 | Substantially Equivalent |