Product code JJW— Clinical Chemistry
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
- Classification name
- Urinalysis Controls (Assayed And Unassayed)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Total cleared
- 61
- First cleared
- Most recent
Market context for product code JJW
FDA has cleared devices under product code JJW between 1976 and 2017, filed by 38 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2017
- 2015
- 2014
- 2011
- 2009
- 2007
- 2005
- 2004
- 2003
- 2002
- 2000
- 1999
- 1998
- 1997
- 1995
Top applicants under product code JJW
Recent clearances under product code JJW
- K170091 — UA-Cellular Complete
- K142262 — AUTION CHECK PLUS
- K131444 — UA-CELLULAR COMPLETE
- K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
- K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
- K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
- K072640 — IRISPEC,CA/CB/CC
- K070848 — LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
- K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS
- K043266 — RANDOX URINE CONTROLS
- K042446 — QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
- K031441 — URICHEMTRAK LIQUID ASSAYED URINE CONTROL
- K031231 — LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
- K023928 — MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
- K022085 — J&S MEDICAL SENTRY URINE DIPSTICK CONTROL
- K021155 — MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
- K000874 — URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
- K992576 — URINE CHEMISTRY CONTROL, LEVEL 1
- K992578 — URINE CHEMISTRY CONTROL, LEVEL 2
- K991917 — OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
- K981933 — URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
- K973451 — MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
- K972710 — QUANTIFY(901)
- K952840 — KENLOR LIQUID TOTAL URINE CONTROL
- K945913 — IRISPEC URINE CHEMISTRY CONTROL PART A AND B
- K943780 — NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
- K942853 — KOVA LIQUA-TROL
- K935062 — MAS LIQUID URINALYSIS CONTROL
- K934257 — U-TROL LIQUID URINE DIPSTICK CONTROL
- K931467 — CHEK-STIX CONTROL STRIPS FOR URINALYSIS
- K902699 — SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)
- K891286 — BIOTROL CHEMISTRY URINE CONTROL
- K890577 — KENLOR LIQUID URINE CONTROL
- K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
- K884424 — LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
- K880496 — LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
- K880495 — LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
- K874890 — QUANTIMETRIX URINE DIPSTICK CONTROL
- K863127 — TESTPACK ACUTE HCG URINGE CONTROLS
- K861756 — V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
- K853603 — CANTROL URINE DIPSTICK CONTROL TWO LEVELS
- K852295 — UROL-GUANT
- K843565 — KOVA TROL I,II, III HUMAN URINE-DRIED
- K842366 — OXALATE URINE CONTROLS NORMAL & ELEVAT
- K840848 — BIOSURE
- K840618 — LIQUI-URA CHEMISTRY URINE CONTROLS
- K832713 — IRI SPEC URINALYSIS CONTROL
- K831526 — URINE TOTAL PROTEIN CONTROL
- K831994 — BIOCHECK POSITIVE URINE CONTROL
- K830834 — NEGATIVE URINE CONTROL
- K822540 — COUNT-10 TROL
- K810917 — KOVA TROL I HUMAN URINE (DRIED)
- K792374 — QUANTITATIVE CONTROL URINE I (HUMAN)
- K792376 — QUANTITATIVE CONTROL URINE II (HUMAN)
- K781961 — CONTROL STRIP FOR VISUAL URINALYSIS
- K781691 — CHEMSTRIP CONTROL
- K780802 — ARMTROL AND FERMTROL
- K780482 — KOVA TROL III
- K771713 — TEK-CHEK-2
- K770390 — URINALYSIS PROFICIENCY
- K760863 — PRODUCT #K3002 KETOTROL-N(URINE CONTROL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.