Atlas FDA

DEB

13 FDA 510(k) clearances · Product code

31 daysmedian time to decision
147 days90th percentile
13clearances measured

FDA profile

Official device name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5620
Medical specialty
Immunology
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RecordFirmDate
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS (K140664)The Binding Site Group , Ltd.2014-04-16
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM (K081249)Dade Behring, Inc.2008-07-21
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (K053073)Dade Behring, Inc.2006-03-28
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (K974564)Beckman Instruments, Inc.1998-02-17
ALPHA-2 MACROGLOBULIN TEST RID KIT (K914389)The Binding Site, Ltd.1991-12-20
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (K896483)Kallestad Diag, A Div. of Erbamont, Inc.1989-12-01
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (K850683)Kent Laboratories, Inc.1985-11-27
RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI (K851282)Cooper Biomedical, Inc.1985-05-24
SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (K850603)Applications Lab1985-03-05
IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO (K812493)Dako Corp.1981-09-23
HUMAN ALPHA2 MACROGLOBULIN (K791340)Beckman Instruments, Inc.1979-08-16
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY (K772246)Kallestad Laboratories, Inc.1977-12-22
LAS-R TM (K771780)Hyland Therapeutic Div., Travenol Laboratories1977-10-04

Track DEB automatically

Every clearance here is in the API, with alerts when new ones post.