DEB — Alpha-2-Macroglobulin, Antigen, Antiserum, Control Class II
FDA product code DEB covers "Alpha-2-Macroglobulin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5620. Submissions are reviewed by the Immunology panel. At least 13 recent 510(k) clearances have been granted under this product code.
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 |