Human Ceruloplasmin
FDA 510(k) K791339 · Beckman Instruments, Inc.
510(k) numberK791339
Submission
- Device name
- Human Ceruloplasmin
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- July 16, 1979
- Decision date
- August 16, 1979
- 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 |
| K851283 | Radial Immunodiffusion Plates-CeruloplasminDDB · Traditional | Cooper Biomedical, Inc. | 05/23/1985SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Human Ceruloplasmin cleared by the FDA?
Human Ceruloplasmin (K791339) received a 510(k) decision of Substantially Equivalent on August 16, 1979, 31 days after the submission was received.
What is the product code of K791339?
The FDA product code is DDB – Ceruloplasmin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5210.