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
11
Registration Numbers
11
Same Product Code
23
Applicant Total
4
Review Days
39
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 |
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