FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA GEL(TM) T SCL-70
K Number: K896461
·
Decision Nov 20, 1989
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
138
Review Days
7
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NOVA GEL(TM) T SCL-70
- K Number
- K896461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- November 13, 1989
- Decision Date
- November 20, 1989
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLL), ordered by most recent decision date.
Alegria Flash CTD Screen
FDA 510(k)
FDA Class 2
·Immunology
Alegria Flash ENA Screen
FDA 510(k)
FDA Class 2
·Immunology
Aptiva CTD Essential Reagent
FDA 510(k)
FDA Class 2
·Immunology
EliA SymphonyS Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash HMGCR Reagents
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
FDA 510(k)
FDA Class 2
·Immunology
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 |