FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K103387 |
ACON LABORATORIES, INC. |
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL |
02/02/2011 |
K052242 |
BAYER HEALTHCARE LLC |
ADVIA CHEMISTRY MICROALBUMIN CONTROLS |
10/03/2005 |
K031231 |
BIO-RAD |
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS |
06/18/2003 |
K000874 |
BIO-RAD |
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 |
04/18/2000 |
K042446 |
BIO-RAD LABORATORIES, INC. |
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS |
11/02/2004 |
K070848 |
BIO-RAD, DIAGNOSTICS GRP. |
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X |
04/25/2007 |
K081908 |
CLINIQA CORPORATION |
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 |
01/16/2009 |
K992576 |
CONSOLIDATED TECHNOLOGIES, INC. |
URINE CHEMISTRY CONTROL, LEVEL 1 |
09/03/1999 |
K992578 |
CONSOLIDATED TECHNOLOGIES, INC. |
URINE CHEMISTRY CONTROL, LEVEL 2 |
09/03/1999 |
K972710 |
HEMATRONIX, INC. |
QUANTIFY(901) |
08/15/1997 |
K072640 |
IRIS DIAGNOSTICS |
IRISPEC,CA/CB/CC |
12/21/2007 |
K022085 |
J & S MEDICAL ASSOC., INC. |
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL |
07/25/2002 |
K973451 |
MEDICAL ANALYSIS SYSTEMS, INC. |
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 |
09/29/1997 |
K023928 |
MEDICAL ANALYSIS SYSTEMS, INC. |
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL |
12/11/2002 |
K021155 |
MEDICAL ANALYSIS SYSTEMS, INC. |
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL |
04/29/2002 |
K981933 |
MEDICAL ANALYSIS SYSTEMS, INC. |
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 |
06/29/1998 |
K031441 |
MEDICAL ANALYSIS SYSTEMS, INC. |
URICHEMTRAK LIQUID ASSAYED URINE CONTROL |
07/01/2003 |
K991917 |
METRIKA, INC. |
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET |
07/12/1999 |
K142262 |
QUANTIMETRIX CORP. |
AUTION CHECK PLUS |
04/10/2015 |
K110846 |
RANDOX LABORATORIES LIMITED |
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 |
09/30/2011 |
K043266 |
RANDOX LABORATORIES, LTD. |
RANDOX URINE CONTROLS |
02/15/2005 |
K170091 |
Streck |
UA-Cellular Complete |
02/09/2017 |
K131444 |
Streck |
UA-CELLULAR COMPLETE |
01/29/2014 |