Ceruloplasmin
FDA 510(k) K161508 · Beckman Coulter Ireland, Inc.
510(k) numberK161508
Submission
- Device name
- Ceruloplasmin
- Applicant
- Beckman Coulter Ireland, Inc.
Co. Clare, IE - Received
- June 1, 2016
- Decision date
- January 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDB – Ceruloplasmin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5210
- Specialty
- Immunology
Other 510(k)s with product code DDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122965 | Human Caeruloplasmin KitDDB · Traditional | The Binding Site Group , Ltd. | 06/03/2013SE |
| K053074 | N Antisera to Human CeruloplasminDDB · Traditional | Dade Behring, Inc. | 03/16/2006SE |
| K964762 | Immage Immunochemistry System Ceruloplasmin (Cer) ReagentDDB · Traditional | Beckman Instruments, Inc. | 04/25/1997SE |
| K913668 | Caeruloplasmin Immunological NL Test KitDDB · Traditional | The Binding Site, Ltd. | 12/20/1991SE |
| K895377 | QM300 Ceruloplasmin Antibody PackDDB · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/21/1989SE |
| K860138 | No. 615 Determination of Ceruloplasmin in SerumDDB · Traditional | Sigma Diagnostics, Inc. | 03/28/1986SE |
| K850682 | 72 Determ. Size Radial Immuno. Test Human CeruloplDDB · Traditional | Kent Laboratories, Inc. | 11/25/1985SE |
| K852247 | Laser Ceruloplasmin Kit(Ceruloplasmin Reagents)DDB · Traditional | Behring Diagnostics, Inc. | 07/10/1985SE |
| K851283 | Radial Immunodiffusion Plates-CeruloplasminDDB · Traditional | Cooper Biomedical, Inc. | 05/23/1985SE |
| K823107 | Quantimetric 2 Ceruloplasmin AssayDDB · Traditional | Kallestad Laboratories, Inc. | 11/16/1982SE |
More from Kallestad Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K182651 | HbA1c AdvancedPDJ · Traditional | 01/16/2019SE |
| K161297 | Beta-2-MicroglobulinJZG · Special | 06/07/2016SE |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin CalibratorDCF · Traditional | 10/15/2014SE |
| 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 Ceruloplasmin cleared by the FDA?
Ceruloplasmin (K161508) received a 510(k) decision of Substantially Equivalent on January 9, 2017, 222 days after the submission was received.
What is the product code of K161508?
The FDA product code is DDB – Ceruloplasmin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5210.