Product code DEB— Immunology
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
- Classification name
- Alpha-2-Macroglobulin, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5620
- Advisory panel
- Immunology
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code DEB
FDA has cleared devices under product code DEB between 1977 and 2014, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2014
- 2008
- 2006
- 1998
- 1991
- 1989
- 1985
- 1981
- 1979
- 1977
Top applicants under product code DEB
Recent clearances under product code DEB
- K140664 — HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
- K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
- K053073 — N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
- K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
- K914389 — ALPHA-2 MACROGLOBULIN TEST RID KIT
- K896483 — QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
- K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
- K851282 — RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI
- K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN
- K812493 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO
- K791340 — HUMAN ALPHA2 MACROGLOBULIN
- K772246 — ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
- K771780 — LAS-R TM
Data sourced from openFDA. This site is unofficial and independent of the FDA.