FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDIA FERRITIN ASSAY
K Number: K920318
·
Decision Jun 4, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
107
Review Days
132
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Basic Information
- Device Name
- CEDIA FERRITIN ASSAY
- K Number
- K920318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Microgenics Corp.
- Date Received
- January 24, 1992
- Decision Date
- June 4, 1992
- Product Code
- JMG
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | FDA class 2 | Immunology |
Similar 510(k) Clearances
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