FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA LITE IGA ACA (HRP)
K Number: K953366
·
Decision Sep 1, 1995
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
93
Applicant Total
138
Review Days
45
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Basic Information
- Device Name
- QUANTA LITE IGA ACA (HRP)
- K Number
- K953366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- July 18, 1995
- Decision Date
- September 1, 1995
- Product Code
- MID
- 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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 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 |
| 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 |