FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTIMUNE FERRITIN IRMA
K Number: K810799
·
Decision Apr 3, 1981
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
319
Review Days
11
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Basic Information
- Device Name
- QUANTIMUNE FERRITIN IRMA
- K Number
- K810799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- March 23, 1981
- Decision Date
- April 3, 1981
- 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
Other 510(k) clearances with the same product code (JMG), ordered by most recent decision date.
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ACE(TM) CEDIA(R) FERRITIN ASSAY
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