Urine/CSF Albumin, Urine/CSF Albumin Calibrator
FDA 510(k) K142346 · Beckman Coulter Ireland, Inc.
510(k) numberK142346
Submission
- Device name
- Urine/CSF Albumin, Urine/CSF Albumin Calibrator
- Applicant
- Beckman Coulter Ireland, Inc.
Co. Clare, IE - Received
- August 22, 2014
- Decision date
- October 15, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5040
- Specialty
- Immunology
Other 510(k)s with product code DCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153560 | Optilite Low Level Albumin KitDCF · Traditional | The Binding Site Group , Ltd. | 08/25/2016SE |
| K143118 | Human Microalbumin kit for use on SPAPLUSDCF · Traditional | The Binding Site Group , Ltd. | 05/26/2015SE |
| K121045 | Human Albumin CSF KitDCF · Traditional | The Binding Site Group , Ltd. | 06/19/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | Roche Diagnostics Operations | 05/14/2012SE |
| K101089 | Easyra Micro-Albumin Reagent and CalibratorDCF · Traditional | Medica Corp. | 07/13/2011SE |
| K101203 | Tina-Quant Albumin Gen 2DCF · Traditional | Roche Diagnostics | 09/10/2010SE |
| K100853 | Cobas 8000 Modular Series AnalyzerDCF · Special | Roche Diagnostics Corp. | 09/09/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | Kamiya Biomedical Co. | 04/29/2010SE |
| K082251 | Synchron Systems Microalbumin (Ma) Reagent, Model 475100DCF · Traditional | Beckman Coulter, Inc. | 04/08/2009SE |
| K061990 | Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…DCF · Traditional | Dade Behring, Inc. | 09/19/2006SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K182651 | HbA1c AdvancedPDJ · Traditional | 01/16/2019SE |
| K161508 | CeruloplasminDDB · Traditional | 01/09/2017SE |
| K161297 | Beta-2-MicroglobulinJZG · Special | 06/07/2016SE |
| K141388 | System CalibraterJIX · Abbreviated | 07/11/2014SE |
| K141374 | Bicarbonate CalibratorJIT · Abbreviated | 06/30/2014SE |
| K131546 | Au Bicarbonate ReagentKHS · Traditional | 10/09/2013SE |
Questions and answers
When was Urine/CSF Albumin, Urine/CSF Albumin Calibrator cleared by the FDA?
Urine/CSF Albumin, Urine/CSF Albumin Calibrator (K142346) received a 510(k) decision of Substantially Equivalent on October 15, 2014, 54 days after the submission was received.
What is the product code of K142346?
The FDA product code is DCF – Albumin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.