FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K Number: K974505
·
Decision Feb 17, 1998
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
3
Review Days
78
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
- K Number
- K974505
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alfa Biotech (Uk) , Ltd.
- Date Received
- December 1, 1997
- Decision Date
- February 17, 1998
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DBF), ordered by most recent decision date.
LIAISON Ferritin
FDA 510(k)
FDA Class 2
·Immunology
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
FDA 510(k)
FDA Class 2
·Immunology
Atellica IM Ferritin Assay
FDA 510(k)
FDA Class 2
·Immunology
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
FDA 510(k)
FDA Class 2
·Immunology
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
FDA 510(k)
FDA Class 2
·Immunology