Radial Immunodiffusion Plates-Ceruloplasmin
FDA 510(k) K851283 · Cooper Biomedical, Inc.
510(k) numberK851283
Submission
- Device name
- Radial Immunodiffusion Plates-Ceruloplasmin
- Applicant
- Cooper Biomedical, Inc.
Malvern, PA, US - Received
- April 1, 1985
- Decision date
- May 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K161508 | CeruloplasminDDB · Traditional | Beckman Coulter Ireland, Inc. | 01/09/2017SE |
| 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 |
| K823107 | Quantimetric 2 Ceruloplasmin AssayDDB · Traditional | Kallestad Laboratories, Inc. | 11/16/1982SE |
More from Kallestad Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | 02/13/1987SE |
| K863868 | Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 AntDFF · Traditional | 02/13/1987SE |
| K863301 | Demand Total ProteinCEK · Traditional | 09/26/1986SE |
| K861926 | Worthington HDL Precipitating Reagent SetLBR · Traditional | 06/27/1986SE |
| K854130 | Demand Ethyl AlcoholDIC · Traditional | 11/05/1985SE |
| K853949 | Demand Acid Phosphatase ReagentCKB · Traditional | 10/16/1985SE |
| K852262 | Assist Clinical Chemistry AnalyzerJJE · Traditional | 06/25/1985SE |
| K851285 | Radial Immunodiffusion Plates CSF Igg & CSF AlbumiDCF · Traditional | 06/17/1985SE |
| K851284 | Radial Immuno-Diffusion Plates Iga, Igd, Igg & IgmCZP · Traditional | 06/11/1985SE |
| K851286 | Radial Immunodiffusion Plates C3 & C4CZW · Traditional | 06/05/1985SE |
Questions and answers
When was Radial Immunodiffusion Plates-Ceruloplasmin cleared by the FDA?
Radial Immunodiffusion Plates-Ceruloplasmin (K851283) received a 510(k) decision of Substantially Equivalent on May 23, 1985, 52 days after the submission was received.
What is the product code of K851283?
The FDA product code is DDB – Ceruloplasmin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5210.