510(k) K081249
- Device
- DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K081249
- Product code
- DEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-21
- Date received
- 2008-05-02
- Regulation
- 866.5620
- Classification name
- Alpha-2-macroglobulin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNA MARIE KATHLEEN ENNIS
- Address
- 500 Gbc Dr., Mailstop 514 Newark DE US 19714 19714
FDA Registration Numbers#
- 3003749380
- 9610126
- 3003741796
- 3014325803
- 2050010
- 3012471076
- 9610806
- 9614373
- 2050012
- 3005452690
- 3019906
Source Documents#
Other 510(k) Records For Product Code DEB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2014-04-16 |
| K053073 | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | Dade Behring, Inc. | 2006-03-28 |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Beckman Instruments, Inc. | 1998-02-17 |
| K914389 | ALPHA-2 MACROGLOBULIN TEST RID KIT | The Binding Site, Ltd. | 1991-12-20 |
| K896483 | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-12-01 |
| K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | Kent Laboratories, Inc. | 1985-11-27 |
| K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | Cooper Biomedical, Inc. | 1985-05-24 |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | Applications Lab | 1985-03-05 |
| K812493 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO | Dako Corp. | 1981-09-23 |
| K791340 | HUMAN ALPHA2 MACROGLOBULIN | Beckman Instruments, Inc. | 1979-08-16 |
| K772246 | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 |
| K771780 | LAS-R TM | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-04 |
Legacy Summary#
summary
FDA Review#
Decision Summary