Atlas FDA

JJW

61 FDA 510(k) clearances · Product code

46 daysmedian time to decision
110 days90th percentile
61clearances measured

FDA profile

Official device name
Urinalysis Controls (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
1994: 1 · 2007: 2 · 2013: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
UA-Cellular Complete (K170091)Streck2017-02-09
AUTION CHECK PLUS (K142262)Quantimetrix Corp.2015-04-10
UA-CELLULAR COMPLETE (K131444)Streck2014-01-29
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (K110846)Randox Laboratories Limited2011-09-30
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL (K103387)ACON Laboratories, Inc.2011-02-02
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (K081908)Cliniqa Corporation2009-01-16
IRISPEC,CA/CB/CC (K072640)Iris Diagnostics2007-12-21
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X (K070848)Bio-Rad, Diagnostics Grp.2007-04-25
ADVIA CHEMISTRY MICROALBUMIN CONTROLS (K052242)Bayer Healthcare, LLC2005-10-03
RANDOX URINE CONTROLS (K043266)Randox Laboratories, Ltd.2005-02-15
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (K042446)Bio-Rad Laboratories, Inc.2004-11-02
URICHEMTRAK LIQUID ASSAYED URINE CONTROL (K031441)Medical Analysis Systems, Inc.2003-07-01
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS (K031231)Bio-Rad2003-06-18
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL (K023928)Medical Analysis Systems, Inc.2002-12-11
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL (K022085)J & S Medical Assoc., Inc.2002-07-25
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL (K021155)Medical Analysis Systems, Inc.2002-04-29
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 (K000874)Bio-Rad2000-04-18
URINE CHEMISTRY CONTROL, LEVEL 1 (K992576)Consolidated Technologies, Inc.1999-09-03
URINE CHEMISTRY CONTROL, LEVEL 2 (K992578)Consolidated Technologies, Inc.1999-09-03
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET (K991917)Metrika, Inc.1999-07-12
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 (K981933)Medical Analysis Systems, Inc.1998-06-29
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 (K973451)Medical Analysis Systems, Inc.1997-09-29
QUANTIFY(901) (K972710)Hematronix, Inc.1997-08-15
KENLOR LIQUID TOTAL URINE CONTROL (K952840)Kenlor Industries, Inc.1995-07-19
IRISPEC URINE CHEMISTRY CONTROL PART A AND B (K945913)International Remote Imaging Systems1995-04-05
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) (K943780)Heraeus Kulzer, Inc.1994-10-31
KOVA LIQUA-TROL (K942853)Hycor Biomedical, Inc.1994-10-04
MAS LIQUID URINALYSIS CONTROL (K935062)Medical Analysis Systems, Inc.1994-01-27
U-TROL LIQUID URINE DIPSTICK CONTROL (K934257)P.T. Meditrol1993-11-26
CHEK-STIX CONTROL STRIPS FOR URINALYSIS (K931467)Heraeus Kulzer, Inc.1993-05-11
SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) (K902699)Actio, Inc.1990-07-16
BIOTROL CHEMISTRY URINE CONTROL (K891286)Biotrol, USA, Inc.1989-04-10
KENLOR LIQUID URINE CONTROL (K890577)Kenlor Industries, Inc.1989-03-09
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (K890534)Fisher Scientific Co., LLC1989-03-08
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) (K884424)Bio-Rad1988-12-15
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) (K880496)Bio-Rad1988-03-16
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) (K880495)Bio-Rad1988-03-15
QUANTIMETRIX URINE DIPSTICK CONTROL (K874890)Quantimetrix Medical Industries1988-01-21
TESTPACK ACUTE HCG URINGE CONTROLS (K863127)Abbott Laboratories1986-09-15
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II (K861756)Texas Immunology, Inc.1986-07-07
CANTROL URINE DIPSTICK CONTROL TWO LEVELS (K853603)Canyon Diagnostics, Inc.1985-10-08
UROL-GUANT (K852295)Dimension Diagnostics1985-07-22
KOVA TROL I,II, III HUMAN URINE-DRIED (K843565)Icl Scientific1984-10-05
OXALATE URINE CONTROLS NORMAL & ELEVAT (K842366)Sigma Chemical Co.1984-09-12
BIOSURE (K840848)Helena Laboratories1984-05-01
LIQUI-URA CHEMISTRY URINE CONTROLS (K840618)Biodiagnostic Intl1984-04-04
IRI SPEC URINALYSIS CONTROL (K832713)Intl. Remote Imaging Systems1983-12-22
URINE TOTAL PROTEIN CONTROL (K831526)Quantimetrix Corp.1983-08-12
BIOCHECK POSITIVE URINE CONTROL (K831994)Helena Laboratories1983-08-08
NEGATIVE URINE CONTROL (K830834)Helena Laboratories1983-04-12
COUNT-10 TROL (K822540)Texas Immunology, Inc.1982-10-08
KOVA TROL I HUMAN URINE (DRIED) (K810917)Icl Scientific1981-04-14
QUANTITATIVE CONTROL URINE I (HUMAN) (K792374)Environmental Chemical Specialties1979-12-06
QUANTITATIVE CONTROL URINE II (HUMAN) (K792376)Environmental Chemical Specialties1979-12-06
CONTROL STRIP FOR VISUAL URINALYSIS (K781961)Miles Laboratories, Inc.1979-02-08
CHEMSTRIP CONTROL (K781691)Boehringer Mannheim Corp.1978-12-20
ARMTROL AND FERMTROL (K780802)Biotron , Ltd.1978-06-13
KOVA TROL III (K780482)Icl Scientific1978-05-03
TEK-CHEK-2 (K771713)Miles Laboratories, Inc.1977-10-18
URINALYSIS PROFICIENCY (K770390)Miles Laboratories, Inc.1977-05-03
PRODUCT #K3002 KETOTROL-N(URINE CONTROL) (K760863)Sigma Chemical Co.1976-11-02

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