FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
K Number: K850410
·
Decision May 8, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
50
Review Days
93
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Basic Information
- Device Name
- GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
- K Number
- K850410
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5715
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Warner-Lambert Co.
- Date Received
- February 4, 1985
- Decision Date
- May 8, 1985
- Product Code
- DDX
- 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 |
|---|---|---|---|
| DDX | Plasminogen, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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