FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYOGLOBIN RIA TEST KIT
K Number: K915233
·
Decision Mar 30, 1992
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
45
Applicant Total
1
Review Days
129
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Basic Information
- Device Name
- MYOGLOBIN RIA TEST KIT
- K Number
- K915233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5680
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pro Diagnostics, Inc.
- Date Received
- November 22, 1991
- Decision Date
- March 30, 1992
- Product Code
- DDR
- 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 |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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