FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY
K Number: K800820
·
Decision Apr 24, 1980
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
41
Review Days
13
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
- AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY
- K Number
- K800820
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5120
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- April 11, 1980
- Decision Date
- April 24, 1980
- Product Code
- DBE
- 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 |
|---|---|---|---|
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DBE), ordered by most recent decision date.
ANTISMOOTH MUSCLE ANTIBODY TEST SYS
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
MEDICA II-F-ASMA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
ANTI-MITOCHONDRIAL
FDA 510(k)
FDA Class 2
·Immunology
TEST, (IVDP) SMOOTHMUSCLE ANTIBODY
FDA 510(k)
FDA Class 2
·Immunology
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 |
| K830214 | AFT SYSTEM III | Mar 9, 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 |