FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFT SYSTEM III
K Number: K830214
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
41
Review Days
44
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Basic Information
- Device Name
- AFT SYSTEM III
- K Number
- K830214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- January 24, 1983
- Decision Date
- March 9, 1983
- 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 |
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Other Clearances by Calbiochem-Behring Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | Jul 28, 1983 | Substantially Equivalent |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | Apr 27, 1983 | Substantially Equivalent |
| K820812 | CREATINE KINASE-MB KIT | Apr 12, 1982 | Substantially Equivalent |
| K813493 | ENZYGNOST TM RUBELLA IGM | Mar 4, 1982 | Substantially Equivalent |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Jan 26, 1982 | Substantially Equivalent |
| 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 |