JJW · Class I · 21 CFR 862.1660

FDA Product Code JJW: Urinalysis Controls (assayed And Unassayed)

Leading manufacturers include Medical Analysis Systems, Inc., Bio-Rad and Miles Laboratories, Inc..

61
Total
61
Cleared
61d
Avg days
1976
Since

FDA 510(k) Cleared Urinalysis Controls (assayed And Unassayed) Devices (Product Code JJW)

61 devices
1–24 of 61
Cleared Feb 09, 2017
UA-Cellular Complete
K170091
Streck
Chemistry · 30d
Cleared Apr 10, 2015
AUTION CHECK PLUS
K142262
Quantimetrix Corp.
Chemistry · 239d
Cleared Jan 29, 2014
UA-CELLULAR COMPLETE
K131444
Streck
Chemistry · 254d
Cleared Sep 30, 2011
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
K110846
Randox Laboratories Limited
Chemistry · 186d
Cleared Feb 02, 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
K103387
ACON Laboratories, Inc.
Chemistry · 76d
Cleared Jan 16, 2009
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908
Cliniqa Corporation
Chemistry · 197d
Cleared Oct 03, 2005
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
K052242
Bayer Healthcare, LLC
Chemistry · 47d
Cleared Feb 15, 2005
RANDOX URINE CONTROLS
K043266
Randox Laboratories, Ltd.
Chemistry · 81d
Cleared Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446
Bio-Rad Laboratories, Inc.
Chemistry · 54d
Cleared Jul 01, 2003
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441
Medical Analysis Systems, Inc.
Chemistry · 56d
Cleared Jun 18, 2003
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
K031231
Bio-Rad
Chemistry · 61d
Cleared Dec 11, 2002
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
K023928
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Apr 29, 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155
Medical Analysis Systems, Inc.
Chemistry · 19d
Cleared Apr 18, 2000
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874
Bio-Rad
Chemistry · 29d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 1
K992576
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 2
K992578
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Jul 12, 1999
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
K991917
Metrika, Inc.
Chemistry · 35d
Cleared Jun 29, 1998
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
K981933
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Sep 29, 1997
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
K973451
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared Aug 15, 1997
QUANTIFY(901)
K972710
Hematronix, Inc.
Chemistry · 25d
Cleared Oct 31, 1994
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
K943780
Heraeus Kulzer, Inc.
Chemistry · 89d
Cleared Oct 04, 1994
KOVA LIQUA-TROL
K942853
Hycor Biomedical, Inc.
Chemistry · 110d
Cleared Jan 27, 1994
MAS LIQUID URINALYSIS CONTROL
K935062
Medical Analysis Systems, Inc.
Chemistry · 99d
Cleared May 11, 1993
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467
Heraeus Kulzer, Inc.
Toxicology · 48d

About Product Code JJW - Regulatory Context