SPQ Test System for ALPHA(2) Macroglobulin
FDA 510(k) K850603 · Applications Lab
510(k) numberK850603
Submission
- Device name
- SPQ Test System for ALPHA(2) Macroglobulin
- Applicant
- Applications Lab
Scarborough, ME, US - Received
- February 15, 1985
- Decision date
- March 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEB – Alpha-2-Macroglobulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5620
- Specialty
- Immunology
Other 510(k)s with product code DEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140664 | Human ALPHA2-MACROGLOBULIN Kit for Use on SpaplusDEB · Traditional | The Binding Site Group , Ltd. | 04/16/2014SE |
| 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 |
| K812493 | Immunogl. Frct. of Rabbit Antiser.-MacroDEB · Traditional | Dako Corp. | 09/23/1981SE |
| K791340 | Human ALPHA2 MacroglobulinDEB · Traditional | Beckman Instruments, Inc. | 08/16/1979SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850587 | SPQ Test System for Alpha, - AntitrypsinDEM · Traditional | 03/14/1985SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | 03/14/1985SE |
| K850589 | SPQ Test System for TransferrinDDG · Traditional | 03/05/1985SE |
| K850588 | SPQ Test System for Complement C3CZW · Traditional | 03/05/1985SE |
| K850584 | SPQ Test System for HaptoglobinDAD · Traditional | 03/05/1985SE |
| K850590 | SPQ Test System for C-Reactive ProteinDCK · Traditional | 03/01/1985SE |
| K850585 | SPQ Test System for Complement C4DBI · Traditional | 03/01/1985SE |
| K850583 | SPQ Test System for Immunoglobulin GDEW · Traditional | 03/01/1985SE |
| K850582 | SPQ Test System for Immunoglobulin aCZP · Traditional | 03/01/1985SE |
Questions and answers
When was SPQ Test System for ALPHA(2) Macroglobulin cleared by the FDA?
SPQ Test System for ALPHA(2) Macroglobulin (K850603) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 18 days after the submission was received.
What is the product code of K850603?
The FDA product code is DEB – Alpha-2-Macroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5620.