DEB — Alpha-2-Macroglobulin, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DEB
- Device Class
- Class II
- Regulation Number
- 866.5620
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K140664 | binding site group | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | April 16, 2014 |
| K081249 | dade behring | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT | July 21, 2008 |
| K053073 | dade behring | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | March 28, 2006 |
| K974564 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | February 17, 1998 |
| K914389 | binding site | ALPHA-2 MACROGLOBULIN TEST RID KIT | December 20, 1991 |
| K896483 | kallestad diag, a div. of erbamont | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK | December 1, 1989 |
| K850683 | kent laboratories | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | November 27, 1985 |
| K851282 | cooper biomedical | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | May 24, 1985 |
| K850603 | applications lab | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | March 5, 1985 |
| K812493 | dako | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO | September 23, 1981 |
| K791340 | beckman instruments | HUMAN ALPHA2 MACROGLOBULIN | August 16, 1979 |
| K772246 | kallestad laboratories | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | December 22, 1977 |
| K771780 | hyland therapeutic div., travenol laboratories | LAS-R TM | October 4, 1977 |