FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Ceruloplasmin
K Number: K161508
·
Decision Jan 9, 2017
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
7
Review Days
222
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Ceruloplasmin
- K Number
- K161508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5210
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter Ireland, Inc.
- Date Received
- June 1, 2016
- Decision Date
- January 9, 2017
- Product Code
- DDB
- 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 |
|---|---|---|---|
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DDB), ordered by most recent decision date.
HUMAN CAERULOPLASMIN KIT
FDA 510(k)
FDA Class 2
·Immunology
N ANTISERA TO HUMAN CERULOPLASMIN
FDA 510(k)
FDA Class 2
·Immunology
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
FDA 510(k)
FDA Class 2
·Immunology
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
QM300 CERULOPLASMIN ANTIBODY PACK
FDA 510(k)
FDA Class 2
·Immunology
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Beckman Coulter Ireland, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182651 | HbA1c Advanced | Jan 16, 2019 | 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 |