FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K991867 |
A.P. TOTAL CARE, INC. |
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 |
08/02/1999 |
K022312 |
ABAXIS, INC. |
PICCOLO PHOSPHORUS TEST SYSTEM |
09/05/2002 |
K981118 |
ABBOTT LABORATORIES |
PHOS |
06/12/1998 |
K981759 |
ABBOTT LABORATORIES |
PHOS |
06/16/1998 |
K072141 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA |
06/24/2008 |
K041643 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT |
08/18/2004 |
K983503 |
BOEHRINGER MANNHEIM CORP. |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 |
12/01/1998 |
K981610 |
CARESIDE, INC. |
CARESIDE ANALYZER |
06/25/1998 |
K971363 |
CAROLINA LIQUID CHEMISTRIES CORP. |
SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT |
04/21/1997 |
K955937 |
DERMA MEDIA LAB., INC. |
INORGANIC PHOSPHORUS REAGENT |
03/12/1996 |
K974858 |
DIAGNOSTIC CHEMICALS LTD. |
PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 |
01/30/1998 |
K030015 |
ELAN DIAGNOSTICS |
ATAC PAK PHOSPHORUS REAGENT |
03/07/2003 |
K981769 |
ELAN PHARMA, INC. |
HICHEM PHOSPHORUS REAGENT KIT |
06/29/1998 |
K003012 |
HEMAGEN DIAGNOSTICS, INC. |
RAICHEM PHOSPORUS REAGENT |
10/25/2000 |
K003912 |
JAS Diagnostics, Inc. |
PHOSPHORUS REAGENT |
02/21/2001 |
K974605 |
RANDOX LABORATORIES, LTD. |
RANDOX INORGANIC PHOSPHOROUS |
01/09/1998 |
K100263 |
SEPPIM S.A.S. |
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS |
05/06/2011 |
K013095 |
WIENER LABORATORIES S.A.I.C. |
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 |
11/16/2001 |