FDA Product Code
FDA Product Code DEB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5620
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2014-04-16 | Traditional | PDF ↗ |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Dade Behring, Inc. | 2008-07-21 | Traditional | PDF ↗ |
| K053073 | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | Dade Behring, Inc. | 2006-03-28 | Traditional | PDF ↗ |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Beckman Instruments, Inc. | 1998-02-17 | Traditional | PDF ↗ |
| K914389 | ALPHA-2 MACROGLOBULIN TEST RID KIT | The Binding Site, Ltd. | 1991-12-20 | Traditional | PDF ↗ |
| K896483 | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-12-01 | Traditional | PDF ↗ |
| K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | Kent Laboratories, Inc. | 1985-11-27 | Traditional | PDF ↗ |
| K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | Cooper Biomedical, Inc. | 1985-05-24 | Traditional | PDF ↗ |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | Applications Lab | 1985-03-05 | Traditional | PDF ↗ |
| K812493 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K791340 | HUMAN ALPHA2 MACROGLOBULIN | Beckman Instruments, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K772246 | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
| K771780 | LAS-R TM | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-04 | Traditional | PDF ↗ |
Product code DEB · Class II · Immunology. Data: openFDA.