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
61 devices
25–48 of 61
Cleared Apr 05, 1995
IRISPEC URINE CHEMISTRY CONTROL PART A AND B
K945913
International Remote Imaging Systems
Chemistry · 124d
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 Nov 26, 1993
U-TROL LIQUID URINE DIPSTICK CONTROL
K934257
P.T. Meditrol
Chemistry · 87d
Cleared May 11, 1993
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467
Heraeus Kulzer, Inc.
Toxicology · 48d
Cleared Jul 16, 1990
SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)
K902699
Actio, Inc.
Chemistry · 27d
Cleared Apr 10, 1989
BIOTROL CHEMISTRY URINE CONTROL
K891286
Biotrol, USA, Inc.
Chemistry · 32d
Cleared Mar 09, 1989
KENLOR LIQUID URINE CONTROL
K890577
Kenlor Industries, Inc.
Chemistry · 31d
Cleared Mar 08, 1989
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
K890534
Fisher Scientific Co., LLC
Chemistry · 41d
Cleared Dec 15, 1988
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424
Bio-Rad
Chemistry · 56d
Cleared Mar 16, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
K880496
Bio-Rad
Chemistry · 41d
Cleared Mar 15, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
K880495
Bio-Rad
Chemistry · 40d
Cleared Jan 21, 1988
QUANTIMETRIX URINE DIPSTICK CONTROL
K874890
Quantimetrix Medical Industries
Chemistry · 51d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG URINGE CONTROLS
K863127
Abbott Laboratories
Chemistry · 31d
Cleared Jul 07, 1986
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
K861756
Texas Immunology, Inc.
Chemistry · 62d
Cleared Oct 08, 1985
CANTROL URINE DIPSTICK CONTROL TWO LEVELS
K853603
Canyon Diagnostics, Inc.
Chemistry · 41d
Cleared Jul 22, 1985
UROL-GUANT
K852295
Dimension Diagnostics
Chemistry · 54d
Cleared Oct 05, 1984
KOVA TROL I,II, III HUMAN URINE-DRIED
K843565
Icl Scientific
Chemistry · 25d
Cleared Sep 12, 1984
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366
Sigma Chemical Co.
Chemistry · 89d
Cleared May 01, 1984
BIOSURE
K840848
Helena Laboratories
Hematology · 67d
Cleared Apr 04, 1984
LIQUI-URA CHEMISTRY URINE CONTROLS
K840618
Biodiagnostic Intl
Chemistry · 50d
Cleared Dec 22, 1983
IRI SPEC URINALYSIS CONTROL
K832713
Intl. Remote Imaging Systems
Chemistry · 132d
Cleared Aug 12, 1983
URINE TOTAL PROTEIN CONTROL
K831526
Quantimetrix Corp.
Chemistry · 92d