FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
K Number: K863868
·
Decision Feb 13, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
19
Review Days
133
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Basic Information
- Device Name
- IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
- K Number
- K863868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5080
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Cooper Biomedical, Inc.
- Date Received
- October 3, 1986
- Decision Date
- February 13, 1987
- Product Code
- DFF
- 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 |
|---|---|---|---|
| DFF | Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Other Clearances by Cooper Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | May 24, 1985 | Substantially Equivalent |