FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRASHIFT 2/4 isatuximab
K Number: K203184
·
Decision Nov 12, 2021
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
28
Applicant Total
10
Review Days
381
Basic Information
- Device Name
- HYDRASHIFT 2/4 isatuximab
- K Number
- K203184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sebia
- Date Received
- October 27, 2020
- Decision Date
- November 12, 2021
- Product Code
- CFF
- 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 |
|---|---|---|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | FDA class 2 | Immunology |
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Other Clearances by Sebia
| K Number | Device Name | ||
|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Apr 4, 2024 | Substantially Equivalent |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Feb 23, 2024 | Substantially Equivalent |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | Nov 18, 2022 | Substantially Equivalent |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Nov 1, 2019 | Substantially Equivalent |
| K190851 | HYDRASHIFT 2/4 daratumumab | May 2, 2019 | Substantially Equivalent |
| K171861 | CAPILLARYS Hb A1c | Feb 7, 2018 | Substantially Equivalent |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | Jan 11, 2018 | Substantially Equivalent |
| K171537 | CAPI 3 Hb A1c | Sep 12, 2017 | Substantially Equivalent |
| K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | Dec 21, 2016 | Substantially Equivalent |