FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
K Number: K191562
·
Decision Mar 6, 2020
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
17
Review Days
267
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Basic Information
- Device Name
- Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
- K Number
- K191562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HORIBA ABX SAS
- Date Received
- June 13, 2019
- Decision Date
- March 6, 2020
- 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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Other Clearances by HORIBA ABX SAS
| K Number | Device Name | ||
|---|---|---|---|
| K232946 | Yumizen H2500 | May 21, 2024 | Substantially Equivalent |
| K193649 | Yumizen C1200 Creatinine PAP | May 10, 2021 | Substantially Equivalent |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | Jun 26, 2020 | Substantially Equivalent |
| K192028 | Yumizen C1200 CRP | Jun 25, 2020 | Substantially Equivalent |
| K191993 | Yumizen C1200 CRP | Oct 3, 2019 | Substantially Equivalent |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Aug 30, 2019 | Substantially Equivalent |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Jul 26, 2019 | Substantially Equivalent |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | Nov 1, 2017 | Substantially Equivalent |
| K151133 | PENTRA XLR | Dec 9, 2015 | Substantially Equivalent |
| K141161 | ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) | Dec 20, 2014 | Substantially Equivalent |