Medical Analysis Systems, Inc. - FDA 510(k) Cleared Devices
107
Total
107
Cleared
0
Denied
90 devices
Cleared
Apr 08, 1997
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
Chemistry
15d
Cleared
Apr 02, 1997
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
Chemistry
16d
Cleared
Apr 23, 1996
IMMUNOLOGY CONTROL
Chemistry
54d
Cleared
Apr 03, 1996
LIPID CONTROL
Chemistry
33d
Cleared
Nov 09, 1995
MAS LIQUID URINALYSIS CONTROL
Chemistry
55d
Cleared
Aug 24, 1995
CSF LIQUID CEREBROSPINAL FLUID CONTROL
Chemistry
62d
Cleared
Mar 21, 1995
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3
Chemistry
186d
Cleared
Aug 18, 1994
TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2
Chemistry
153d
Cleared
Jul 06, 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS
Chemistry
294d
Cleared
Jan 27, 1994
MAS LIQUID URINALYSIS CONTROL
Chemistry
99d
Cleared
Oct 18, 1993
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3
Chemistry
60d
Cleared
Feb 03, 1993
REFLAB SYSTEM PACK LIQUID CO2 REAGENT
Chemistry
50d
Cleared
Sep 02, 1992
MONI-TROL-L AND MONI-TROL-XL
Chemistry
224d
Cleared
Aug 04, 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
Chemistry
187d
Cleared
Mar 17, 1992
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3
Chemistry
180d
Cleared
Apr 12, 1991
CHALLENGE (TM) LIQ THERA DRUG CONTROLS
Chemistry
77d
Cleared
Dec 11, 1990
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
Chemistry
42d
Cleared
Nov 01, 1990
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
Chemistry
56d
Cleared
Sep 07, 1990
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
Chemistry
45d
Cleared
Aug 17, 1990
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY
Chemistry
29d
Cleared
Aug 17, 1990
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT
Chemistry
25d
Cleared
Mar 19, 1990
IRON LIQUID STABLE REAGENT
Chemistry
20d
Cleared
Feb 27, 1990
DIRECT BILIRUBIN REAGENT
Chemistry
41d
Cleared
Aug 11, 1989
DIRECT BILIRUBIN REAGENT
Chemistry
86d
Cleared
Jul 20, 1989
ACID PHOSPHATASE REAGENT
Chemistry
104d
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