FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPI 3 Hb A1c
K Number: K171537
·
Decision Sep 12, 2017
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
32
Review Days
110
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Basic Information
- Device Name
- CAPI 3 Hb A1c
- K Number
- K171537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sebia
- Date Received
- May 25, 2017
- Decision Date
- September 12, 2017
- Product Code
- PDJ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| PDJ | Hemoglobin A1c Test System | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | Nov 18, 2022 | Substantially Equivalent |
| K203184 | HYDRASHIFT 2/4 isatuximab | Nov 12, 2021 | Substantially Equivalent |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Nov 1, 2019 | Substantially Equivalent |
| K190851 | HYDRASHIFT 2/4 daratumumab | May 2, 2019 | Substantially Equivalent |
| K180762 | CAPI 3 HEMOGLOBIN(E) | Dec 14, 2018 | Substantially Equivalent |
| K171861 | CAPILLARYS Hb A1c | Feb 7, 2018 | Substantially Equivalent |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | Jan 11, 2018 | Substantially Equivalent |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Feb 17, 2017 | Substantially Equivalent |