Urinalysis Controls (Assayed And Unassayed)

FDA product code JJW · 59 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1660
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-02 – 2017-02-09

JJW 2017-02-09

UA-Cellular Complete

Applicant Streck

K number K170091

View details →

JJW 2011-09-30

RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2

Applicant Randox Laboratories Limited

K number K110846

View details →

JJW 2011-02-02

MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL

Applicant ACON Laboratories, Inc.

K number K103387

View details →

JJW 2009-01-16

CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2

Applicant Cliniqa Corporation

K number K081908

View details →

JJW 2007-12-21

IRISPEC,CA/CB/CC

Applicant Iris Diagnostics

K number K072640

View details →

JJW 2007-04-25

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X

Applicant Bio-Rad, Diagnostics Grp.

K number K070848

View details →

JJW 2005-10-03

ADVIA CHEMISTRY MICROALBUMIN CONTROLS

Applicant Bayer Healthcare, LLC

K number K052242

View details →

JJW 2005-02-15

RANDOX URINE CONTROLS

Applicant Randox Laboratories, Ltd.

K number K043266

View details →

JJW 2004-11-02

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS

Applicant Bio-Rad Laboratories, Inc.

K number K042446

View details →

JJW 2003-07-01

URICHEMTRAK LIQUID ASSAYED URINE CONTROL

Applicant Medical Analysis Systems, Inc.

K number K031441

View details →

JJW 2003-06-18

LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS

Applicant Bio-Rad

K number K031231

View details →

JJW 2002-12-11

MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL

Applicant Medical Analysis Systems, Inc.

K number K023928

View details →

JJW 2002-07-25

J&S MEDICAL SENTRY URINE DIPSTICK CONTROL

Applicant J & S Medical Assoc., Inc.

K number K022085

View details →

JJW 2002-04-29

MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL

Applicant Medical Analysis Systems, Inc.

K number K021155

View details →

JJW 2000-04-18

URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100

Applicant Bio-Rad

K number K000874

View details →

JJW 1999-09-03

URINE CHEMISTRY CONTROL, LEVEL 2

Applicant Consolidated Technologies, Inc.

K number K992578

View details →

JJW 1999-09-03

URINE CHEMISTRY CONTROL, LEVEL 1

Applicant Consolidated Technologies, Inc.

K number K992576

View details →

JJW 1999-07-12

OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET

Applicant Metrika, Inc.

K number K991917

View details →

JJW 1998-06-29

URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2

Applicant Medical Analysis Systems, Inc.

K number K981933

View details →

JJW 1997-09-29

MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3

Applicant Medical Analysis Systems, Inc.

K number K973451

View details →

JJW 1997-08-15

QUANTIFY(901)

Applicant Hematronix, Inc.

K number K972710

View details →

JJW 1995-07-19

KENLOR LIQUID TOTAL URINE CONTROL

Applicant Kenlor Industries, Inc.

K number K952840

View details →

JJW 1995-04-05

IRISPEC URINE CHEMISTRY CONTROL PART A AND B

Applicant International Remote Imaging Systems

K number K945913

View details →

JJW 1994-10-31

NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)

Applicant Heraeus Kulzer, Inc.

K number K943780

View details →

JJW 1994-10-04

KOVA LIQUA-TROL

Applicant Hycor Biomedical, Inc.

K number K942853

View details →

JJW 1994-01-27

MAS LIQUID URINALYSIS CONTROL

Applicant Medical Analysis Systems, Inc.

K number K935062

View details →

JJW 1993-11-26

U-TROL LIQUID URINE DIPSTICK CONTROL

Applicant P.T. Meditrol

K number K934257

View details →

JJW 1993-05-11

CHEK-STIX CONTROL STRIPS FOR URINALYSIS

Applicant Heraeus Kulzer, Inc.

K number K931467

View details →

JJW 1990-07-16

SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)

Applicant Actio, Inc.

K number K902699

View details →

JJW 1989-04-10

BIOTROL CHEMISTRY URINE CONTROL

Applicant Biotrol, USA, Inc.

K number K891286

View details →

JJW 1989-03-09

KENLOR LIQUID URINE CONTROL

Applicant Kenlor Industries, Inc.

K number K890577

View details →

JJW 1989-03-08

MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1

Applicant Fisher Scientific Co., LLC

K number K890534

View details →

JJW 1988-12-15

LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)

Applicant Bio-Rad

K number K884424

View details →

JJW 1988-03-16

LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)

Applicant Bio-Rad

K number K880496

View details →

JJW 1988-03-15

LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)

Applicant Bio-Rad

K number K880495

View details →

JJW 1988-01-21

QUANTIMETRIX URINE DIPSTICK CONTROL

Applicant Quantimetrix Medical Industries

K number K874890

View details →

JJW 1986-09-15

TESTPACK ACUTE HCG URINGE CONTROLS

Applicant Abbott Laboratories

K number K863127

View details →

JJW 1986-07-07

V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II

Applicant Texas Immunology, Inc.

K number K861756

View details →

JJW 1985-10-08

CANTROL URINE DIPSTICK CONTROL TWO LEVELS

Applicant Canyon Diagnostics, Inc.

K number K853603

View details →

JJW 1985-07-22

UROL-GUANT

Applicant Dimension Diagnostics

K number K852295

View details →

JJW 1984-10-05

KOVA TROL I,II, III HUMAN URINE-DRIED

Applicant Icl Scientific

K number K843565

View details →

JJW 1984-09-12

OXALATE URINE CONTROLS NORMAL & ELEVAT

Applicant Sigma Chemical Co.

K number K842366

View details →

JJW 1984-05-01

BIOSURE

Applicant Helena Laboratories

K number K840848

View details →

JJW 1984-04-04

LIQUI-URA CHEMISTRY URINE CONTROLS

Applicant Biodiagnostic Intl

K number K840618

View details →

JJW 1983-12-22

IRI SPEC URINALYSIS CONTROL

Applicant Intl. Remote Imaging Systems

K number K832713

View details →

JJW 1983-08-12

URINE TOTAL PROTEIN CONTROL

Applicant Quantimetrix Corp.

K number K831526

View details →

JJW 1983-08-08

BIOCHECK POSITIVE URINE CONTROL

Applicant Helena Laboratories

K number K831994

View details →

JJW 1983-04-12

NEGATIVE URINE CONTROL

Applicant Helena Laboratories

K number K830834

View details →

JJW 1982-10-08

COUNT-10 TROL

Applicant Texas Immunology, Inc.

K number K822540

View details →

JJW 1981-04-14

KOVA TROL I HUMAN URINE (DRIED)

Applicant Icl Scientific

K number K810917

View details →

JJW 1979-12-06

QUANTITATIVE CONTROL URINE II (HUMAN)

Applicant Environmental Chemical Specialties

K number K792376

View details →

JJW 1979-12-06

QUANTITATIVE CONTROL URINE I (HUMAN)

Applicant Environmental Chemical Specialties

K number K792374

View details →

JJW 1979-02-08

CONTROL STRIP FOR VISUAL URINALYSIS

Applicant Miles Laboratories, Inc.

K number K781961

View details →

JJW 1978-12-20

CHEMSTRIP CONTROL

Applicant Boehringer Mannheim Corp.

K number K781691

View details →

JJW 1978-06-13

ARMTROL AND FERMTROL

Applicant Biotron , Ltd.

K number K780802

View details →

JJW 1978-05-03

KOVA TROL III

Applicant Icl Scientific

K number K780482

View details →

JJW 1977-10-18

TEK-CHEK-2

Applicant Miles Laboratories, Inc.

K number K771713

View details →

JJW 1977-05-03

URINALYSIS PROFICIENCY

Applicant Miles Laboratories, Inc.

K number K770390

View details →

JJW 1976-11-02

PRODUCT #K3002 KETOTROL-N(URINE CONTROL)

Applicant Sigma Chemical Co.

K number K760863

View details →