FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
K Number: K791928
·
Decision Nov 13, 1979
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
109
Applicant Total
1
Review Days
47
Basic Information
- Device Name
- ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
- K Number
- K791928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- KEITH E. ABBOTT
- Date Received
- September 27, 1979
- Decision Date
- November 13, 1979
- Product Code
- DHN
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHN), ordered by most recent decision date.
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
FDA 510(k)
FDA Class 2
·Immunology
ImmuGlo HEp-2 Elite IFA
FDA 510(k)
FDA Class 2
·Immunology
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Image Navigator by Immuno Concepts
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
FDA 510(k)
FDA Class 2
·Immunology
NOVA Lite DAPI ANA Kit
FDA 510(k)
FDA Class 2
·Immunology