FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
K Number: K851287
·
Decision May 24, 1985
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
19
Review Days
53
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
- RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
- K Number
- K851287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5880
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Cooper Biomedical, Inc.
- Date Received
- April 1, 1985
- Decision Date
- May 24, 1985
- Product Code
- DDG
- 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 |
|---|---|---|---|
| DDG | Transferrin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DDG), ordered by most recent decision date.
Access sTfR
FDA 510(k)
FDA Class 2
·Immunology
Transferrin
FDA 510(k)
FDA Class 2
·Immunology
Tina-quant Transferrin ver.2 (urine application)
FDA 510(k)
FDA Class 2
·Immunology
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
FDA 510(k)
FDA Class 2
·Immunology
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Cooper Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863868 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT | Feb 13, 1987 | Substantially Equivalent |
| K864512 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | Feb 13, 1987 | Substantially Equivalent |
| K863301 | DEMAND TOTAL PROTEIN | Sep 26, 1986 | Substantially Equivalent |
| K861926 | WORTHINGTON HDL PRECIPITATING REAGENT SET | Jun 27, 1986 | Substantially Equivalent |
| K854130 | DEMAND ETHYL ALCOHOL | Nov 5, 1985 | Substantially Equivalent |
| K853949 | DEMAND ACID PHOSPHATASE REAGENT | Oct 16, 1985 | Substantially Equivalent |
| K852262 | ASSIST CLINICAL CHEMISTRY ANALYZER | Jun 25, 1985 | Substantially Equivalent |
| K851285 | RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI | Jun 17, 1985 | Substantially Equivalent |
| K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM | Jun 11, 1985 | Substantially Equivalent |
| K851286 | RADIAL IMMUNODIFFUSION PLATES C3 & C4 | Jun 5, 1985 | Substantially Equivalent |