Panels › Clinical Chemistry › Product code JJW · Class 1
Urinalysis Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (61 all time)
1recalls in 12 months (22 all time)
17recalls that name a 510(k)
Top companies in JJW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 2017 | K170091 | UA-Cellular Complete Streck | JJW |
| Apr 10, 2015 | K142262 | AUTION CHECK PLUS Quantimetrix Corp. | JJW |
| Jan 29, 2014 | K131444 | UA-CELLULAR COMPLETE Streck | JJW |
| Sep 30, 2011 | K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 Randox Laboratories Limited, GB | JJW |
| Feb 2, 2011 | K103387 | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL ACON Laboratories, Inc. | JJW |
| Jan 16, 2009 | K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 Cliniqa Corporation | JJW |
| Dec 21, 2007 | K072640 | IRISPEC,CA/CB/CC Iris Diagnostics | JJW |
| Apr 25, 2007 | K070848 | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X Bio-Rad, Diagnostics Grp. | JJW |
| Oct 3, 2005 | K052242 | ADVIA CHEMISTRY MICROALBUMIN CONTROLS Bayer Healthcare, LLC | JJW |
| Feb 15, 2005 | K043266 | RANDOX URINE CONTROLS Randox Laboratories, Ltd., GB | JJW |
| Nov 2, 2004 | K042446 | QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS Bio-Rad Laboratories, Inc. | JJW |
| Jul 1, 2003 | K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL Medical Analysis Systems, Inc. | JJW |
| Jun 18, 2003 | K031231 | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS Bio-Rad | JJW |
| Dec 11, 2002 | K023928 | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJW |
| Jul 25, 2002 | K022085 | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL J & S Medical Assoc., Inc. | JJW |
| Apr 29, 2002 | K021155 | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJW |
| Apr 18, 2000 | K000874 | URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 Bio-Rad | JJW |
| Sep 3, 1999 | K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 Consolidated Technologies, Inc. | JJW |
| Sep 3, 1999 | K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 Consolidated Technologies, Inc. | JJW |
| Jul 12, 1999 | K991917 | OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET Metrika, Inc. | JJW |
| Jun 29, 1998 | K981933 | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 Medical Analysis Systems, Inc. | JJW |
| Sep 29, 1997 | K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 Medical Analysis Systems, Inc. | JJW |
| Aug 15, 1997 | K972710 | QUANTIFY(901) Hematronix, Inc. | JJW |
| Jul 19, 1995 | K952840 | KENLOR LIQUID TOTAL URINE CONTROL Kenlor Industries, Inc. | JJW |
| Apr 5, 1995 | K945913 | IRISPEC URINE CHEMISTRY CONTROL PART A AND B International Remote Imaging Systems | JJW |
| Oct 31, 1994 | K943780 | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) Heraeus Kulzer, Inc. | JJW |
| Oct 4, 1994 | K942853 | KOVA LIQUA-TROL Hycor Biomedical, Inc. | JJW |
| Jan 27, 1994 | K935062 | MAS LIQUID URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJW |
| Nov 26, 1993 | K934257 | U-TROL LIQUID URINE DIPSTICK CONTROL P.T. Meditrol, ID | JJW |
| May 11, 1993 | K931467 | CHEK-STIX CONTROL STRIPS FOR URINALYSIS Heraeus Kulzer, Inc. | JJW |
| Jul 16, 1990 | K902699 | SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) Actio, Inc. | JJW |
| Apr 10, 1989 | K891286 | BIOTROL CHEMISTRY URINE CONTROL Biotrol, USA, Inc. | JJW |
| Mar 9, 1989 | K890577 | KENLOR LIQUID URINE CONTROL Kenlor Industries, Inc. | JJW |
| Mar 8, 1989 | K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 Fisher Scientific Co., LLC | JJW |
| Dec 15, 1988 | K884424 | LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) Bio-Rad | JJW |
| Mar 16, 1988 | K880496 | LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) Bio-Rad | JJW |
| Mar 15, 1988 | K880495 | LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) Bio-Rad | JJW |
| Jan 21, 1988 | K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL Quantimetrix Medical Industries | JJW |
| Sep 15, 1986 | K863127 | TESTPACK ACUTE HCG URINGE CONTROLS Abbott Laboratories | JJW |
| Jul 7, 1986 | K861756 | V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II Texas Immunology, Inc. | JJW |
| Oct 8, 1985 | K853603 | CANTROL URINE DIPSTICK CONTROL TWO LEVELS Canyon Diagnostics, Inc. | JJW |
| Jul 22, 1985 | K852295 | UROL-GUANT Dimension Diagnostics | JJW |
| Oct 5, 1984 | K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED Icl Scientific | JJW |
| Sep 12, 1984 | K842366 | OXALATE URINE CONTROLS NORMAL & ELEVAT Sigma Chemical Co. | JJW |
| May 1, 1984 | K840848 | BIOSURE Helena Laboratories | JJW |
| Apr 4, 1984 | K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS Biodiagnostic Intl | JJW |
| Dec 22, 1983 | K832713 | IRI SPEC URINALYSIS CONTROL Intl. Remote Imaging Systems | JJW |
| Aug 12, 1983 | K831526 | URINE TOTAL PROTEIN CONTROL Quantimetrix Corp. | JJW |
| Aug 8, 1983 | K831994 | BIOCHECK POSITIVE URINE CONTROL Helena Laboratories | JJW |
| Apr 12, 1983 | K830834 | NEGATIVE URINE CONTROL Helena Laboratories | JJW |
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