FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
HbA1c Advanced
K Number: K182651
·
Decision Jan 16, 2019
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
7
Review Days
114
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Basic Information
- Device Name
- HbA1c Advanced
- K Number
- K182651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter Ireland, Inc.
- Date Received
- September 24, 2018
- Decision Date
- January 16, 2019
- 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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Other Clearances by Beckman Coulter Ireland, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161508 | Ceruloplasmin | Jan 9, 2017 | Substantially Equivalent |
| K161297 | Beta-2-Microglobulin | Jun 7, 2016 | Substantially Equivalent |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | Oct 15, 2014 | Substantially Equivalent |
| K141388 | SYSTEM CALIBRATER | Jul 11, 2014 | Substantially Equivalent |
| K141374 | BICARBONATE CALIBRATOR | Jun 30, 2014 | Substantially Equivalent |
| K131546 | AU BICARBONATE REAGENT | Oct 9, 2013 | Substantially Equivalent |