FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA GEL(TM) SM/RNP
K Number: K881181
·
Decision Apr 6, 1988
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
177
Applicant Total
126
Review Days
35
Basic Information
- Device Name
- NOVA GEL(TM) SM/RNP
- K Number
- K881181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- INOVA DIAGNOSTICS, INC.
- Date Received
- March 2, 1988
- Decision Date
- April 6, 1988
- 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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|---|---|---|---|
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| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | Sep 21, 2015 | Substantially Equivalent |
| DEN140039 | NOVA View Automated Fluorescense Microscope | Apr 9, 2015 | Unknown |
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