FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
K Number: K971658
·
Decision May 23, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
4
Review Days
39
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
- MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
- K Number
- K971658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jay H. Geller
- Date Received
- April 14, 1997
- Decision Date
- May 23, 1997
- Product Code
- DBL
- 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 |
|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DBL), ordered by most recent decision date.
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
FDA 510(k)
FDA Class 2
·Immunology
NOVA LITE ENDOMYSIAL
FDA 510(k)
FDA Class 2
·Immunology
WIELISA ANTI-GBM TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
FDA 510(k)
FDA Class 2
·Immunology
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
FDA 510(k)
FDA Class 2
·Immunology
RIT LIVER, KIDNEY, STOMACH IFA KIT
FDA 510(k)
FDA Class 2
·Immunology