FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Urine/CSF Albumin, Urine/CSF Albumin Calibrator
K Number: K142346
·
Decision Oct 15, 2014
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
36
Applicant Total
7
Review Days
54
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Basic Information
- Device Name
- Urine/CSF Albumin, Urine/CSF Albumin Calibrator
- K Number
- K142346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter Ireland, Inc.
- Date Received
- August 22, 2014
- Decision Date
- October 15, 2014
- Product Code
- DCF
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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|---|---|---|---|
| K182651 | HbA1c Advanced | Jan 16, 2019 | Substantially Equivalent |
| K161508 | Ceruloplasmin | Jan 9, 2017 | Substantially Equivalent |
| K161297 | Beta-2-Microglobulin | Jun 7, 2016 | 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 |