FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RABBIT COMPLEMENT
K Number: K791117
·
Decision Aug 3, 1979
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
41
Review Days
49
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
- RABBIT COMPLEMENT
- K Number
- K791117
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- June 15, 1979
- Decision Date
- August 3, 1979
- Product Code
- KTQ
- Advisory Committee
- Immunology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KTQ | Reagent, Complement | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTQ), ordered by most recent decision date.
SPQ(TM) ANTIBODY REAGENT SET II FOR C3
FDA 510(k)
FDA Class 1
·Immunology
RABBIT COMPLEMENT
FDA 510(k)
FDA Class 1
·Immunology
GUINEA PIG COMPLEMENT REGULAR
FDA 510(k)
FDA Class 1
·Immunology
GUINEA PIG COMPLEMENT VIRUS ANTIBODY
FDA 510(k)
FDA Class 1
·Immunology
LOW-TOX-H RABBIT COMPLEMENT
FDA 510(k)
FDA Class 1
·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 |