FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SEKURE HbA1c Assay
K Number: K173206
·
Decision Jul 12, 2018
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
6
Review Days
283
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Basic Information
- Device Name
- SEKURE HbA1c Assay
- K Number
- K173206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Date Received
- October 2, 2017
- Decision Date
- July 12, 2018
- 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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