Human ALPHA2-MACROGLOBULIN Kit for Use on Spaplus
FDA 510(k) K140664 · The Binding Site Group , Ltd.
510(k) numberK140664
Submission
- Device name
- Human ALPHA2-MACROGLOBULIN Kit for Use on Spaplus
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- March 18, 2014
- Decision date
- April 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DEB – Alpha-2-Macroglobulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5620
- Specialty
- Immunology
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|---|---|---|---|
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | Dade Behring, Inc. | 07/21/2008SE |
| K053073 | N Antisera to Human ALPHA2-MACROGLOBULINDEB · Traditional | Dade Behring, Inc. | 03/28/2006SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | Beckman Instruments, Inc. | 02/17/1998SE |
| K914389 | ALPHA-2 Macroglobulin Test Rid KitDEB · Traditional | The Binding Site, Ltd. | 12/20/1991SE |
| K896483 | QM300 ALPHA2 Macroglobulin Antibody PackDEB · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 12/01/1989SE |
| K850683 | 72 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional | Kent Laboratories, Inc. | 11/27/1985SE |
| K851282 | Radial Immunodiffusion Plates ALPHA-2 MacroglobuliDEB · Traditional | Cooper Biomedical, Inc. | 05/24/1985SE |
| K850603 | SPQ Test System for ALPHA(2) MacroglobulinDEB · Traditional | Applications Lab | 03/05/1985SE |
| K812493 | Immunogl. Frct. of Rabbit Antiser.-MacroDEB · Traditional | Dako Corp. | 09/23/1981SE |
| K791340 | Human ALPHA2 MacroglobulinDEB · Traditional | Beckman Instruments, Inc. | 08/16/1979SE |
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Questions and answers
When was Human ALPHA2-MACROGLOBULIN Kit for Use on Spaplus cleared by the FDA?
Human ALPHA2-MACROGLOBULIN Kit for Use on Spaplus (K140664) received a 510(k) decision of Substantially Equivalent on April 16, 2014, 29 days after the submission was received.
What is the product code of K140664?
The FDA product code is DEB – Alpha-2-Macroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5620.