FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Beta-2-Microglobulin
K Number: K161297
·
Decision Jun 7, 2016
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
52
Applicant Total
7
Review Days
29
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Basic Information
- Device Name
- Beta-2-Microglobulin
- K Number
- K161297
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5630
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter Ireland, Inc.
- Date Received
- May 9, 2016
- Decision Date
- June 7, 2016
- Product Code
- JZG
- 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 |
|---|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological | FDA class 2 | Immunology |
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Other Clearances by Beckman Coulter Ireland, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182651 | HbA1c Advanced | Jan 16, 2019 | Substantially Equivalent |
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| 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 |