FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K983440 |
ABBOTT LABORATORIES |
ABBOTT ARCHITECT TOTAL T4 |
11/25/1998 |
K131515 |
ALFA WASSERMANN |
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT |
08/14/2013 |
K023369 |
BECKMAN COULTER, INC. |
ACCESS TOTAL T4 ASSAY |
12/09/2002 |
K971203 |
BECKMAN INSTRUMENTS, INC. |
SYNCHRON SYSTEMS THYROXINE REAGENT |
05/16/1997 |
K991432 |
BIOCHECK, INC. |
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 |
06/02/1999 |
K982298 |
BIOTECX LABORATORIES, INC. |
OPTICOAT T4 EIA KIT |
02/03/1999 |
K971269 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
DSL ACTIVE T4 EIA |
05/22/1997 |
K951014 |
ISOLAB, INC. |
ISOLAB'S T4 TEST KIT |
10/18/1996 |
K964721 |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) |
12/18/1996 |
K030860 |
MONOBIND |
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 |
08/22/2003 |
K971709 |
MONOBIND |
TOTAL THROXINE MICROPLATE EIA(225-300) |
06/16/1997 |
K972974 |
NEOMETRICS, INC. |
ACCUWELL T4-EIA |
10/06/1997 |
K160495 |
Ortho-Clinical Diagnostics, Inc. |
VITROS« Automation Solutions |
10/18/2016 |
K001603 |
REPROMEDIX CORP. |
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) |
10/05/2000 |
K981377 |
SCHIAPPARELLI BIOSYSTEMS, INC. |
ACE T4 REAGENT T4 CALIBRATORS |
06/10/1998 |
K082638 |
Siemens Healthcare Diagnostics Inc. |
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL |
02/26/2009 |
K000600 |
SYVA CO., DADE BEHRING, INC. |
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS |
03/27/2000 |
K962211 |
UNITED BIOTECH, INC. |
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE |
07/08/1996 |
K103484 |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
GSP NEONATAL THYROXINE (T4) |
04/22/2011 |