FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENA TEST KIT SM & RNP AUTO ANTIBODY
K Number: K831036
·
Decision Apr 27, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
41
Review Days
27
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Basic Information
- Device Name
- ENA TEST KIT SM & RNP AUTO ANTIBODY
- K Number
- K831036
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- March 31, 1983
- Decision Date
- April 27, 1983
- 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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| K812458 | PADAC | Sep 23, 1981 | Substantially Equivalent |
| K810718 | C-PEPTICE REAGENTS | Mar 31, 1981 | Substantially Equivalent |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent |
| K810404 | RHEUMATOID FACTORS REFERENCE SERUM | Mar 11, 1981 | Substantially Equivalent |