FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALBIOCHEM-BEHRING RIA-COUNT
K Number: K792460
·
Decision Feb 13, 1980
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
41
Review Days
72
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
- CALBIOCHEM-BEHRING RIA-COUNT
- K Number
- K792460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- December 3, 1979
- Decision Date
- February 13, 1980
- Product Code
- CDD
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDD), ordered by most recent decision date.
ARCHITECT Active-B12 (Holotranscobalamin)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Vitamin B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIAISON Vitamin B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |