FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K Number: K801676
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
883
Review Days
29
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Basic Information
- Device Name
- FERRIZYME FERRITIN ENZYME IMMUNOASSAY
- K Number
- K801676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- July 22, 1980
- Decision Date
- August 20, 1980
- Product Code
- DBF
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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