Caeruloplasmin Immunological NL Test Kit
FDA 510(k) K913668 · The Binding Site, Ltd.
510(k) numberK913668
Submission
- Device name
- Caeruloplasmin Immunological NL Test Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- August 19, 1991
- Decision date
- December 20, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Caeruloplasmin Immunological NL Test Kit cleared by the FDA?
Caeruloplasmin Immunological NL Test Kit (K913668) received a 510(k) decision of Substantially Equivalent on December 20, 1991, 123 days after the submission was received.
What is the product code of K913668?
The FDA product code is DDB – Ceruloplasmin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5210.