ALPHA-2-MACROGLOBULIN Nephel. Assay
FDA 510(k) K772246 · Kallestad Laboratories, Inc.
510(k) numberK772246
Submission
- Device name
- ALPHA-2-MACROGLOBULIN Nephel. Assay
- Applicant
- Kallestad Laboratories, Inc.
Walker, MI, US - Received
- December 9, 1977
- Decision date
- December 22, 1977
- 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
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|---|---|---|---|
| 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 |
| 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 |
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
Questions and answers
When was ALPHA-2-MACROGLOBULIN Nephel. Assay cleared by the FDA?
ALPHA-2-MACROGLOBULIN Nephel. Assay (K772246) received a 510(k) decision of Substantially Equivalent on December 22, 1977, 13 days after the submission was received.
What is the product code of K772246?
The FDA product code is DEB – Alpha-2-Macroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5620.