FDA Product Code
FDA Product Code JJW — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170091 | UA-Cellular Complete | Streck | 2017-02-09 | Traditional | PDF ↗ |
| K142262 | AUTION CHECK PLUS | Quantimetrix Corp. | 2015-04-10 | Traditional | PDF ↗ |
| K131444 | UA-CELLULAR COMPLETE | Streck | 2014-01-29 | Traditional | PDF ↗ |
| K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | Randox Laboratories Limited | 2011-09-30 | Traditional | PDF ↗ |
| K103387 | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL | ACON Laboratories, Inc. | 2011-02-02 | Traditional | PDF ↗ |
| K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | Cliniqa Corporation | 2009-01-16 | Traditional | PDF ↗ |
| K072640 | IRISPEC,CA/CB/CC | Iris Diagnostics | 2007-12-21 | Abbreviated | PDF ↗ |
| K070848 | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X | Bio-Rad, Diagnostics Grp. | 2007-04-25 | Traditional | PDF ↗ |
| K052242 | ADVIA CHEMISTRY MICROALBUMIN CONTROLS | Bayer Healthcare, LLC | 2005-10-03 | Abbreviated | PDF ↗ |
| K043266 | RANDOX URINE CONTROLS | Randox Laboratories, Ltd. | 2005-02-15 | Traditional | PDF ↗ |
| K042446 | QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS | Bio-Rad Laboratories, Inc. | 2004-11-02 | Traditional | PDF ↗ |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | Medical Analysis Systems, Inc. | 2003-07-01 | Traditional | PDF ↗ |
| K031231 | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS | Bio-Rad | 2003-06-18 | Traditional | PDF ↗ |
| K023928 | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 2002-12-11 | Traditional | PDF ↗ |
| K022085 | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL | J & S Medical Assoc., Inc. | 2002-07-25 | Traditional | PDF ↗ |
| K021155 | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 2002-04-29 | Traditional | PDF ↗ |
| K000874 | URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 | Bio-Rad | 2000-04-18 | Traditional | PDF ↗ |
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | Consolidated Technologies, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | Consolidated Technologies, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K991917 | OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET | Metrika, Inc. | 1999-07-12 | Traditional | PDF ↗ |
| K981933 | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 | Medical Analysis Systems, Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 | Medical Analysis Systems, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K972710 | QUANTIFY(901) | Hematronix, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K952840 | KENLOR LIQUID TOTAL URINE CONTROL | Kenlor Industries, Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K945913 | IRISPEC URINE CHEMISTRY CONTROL PART A AND B | International Remote Imaging Systems | 1995-04-05 | Traditional | PDF ↗ |
| K943780 | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) | Heraeus Kulzer, Inc. | 1994-10-31 | Traditional | PDF ↗ |
| K942853 | KOVA LIQUA-TROL | Hycor Biomedical, Inc. | 1994-10-04 | Traditional | PDF ↗ |
| K935062 | MAS LIQUID URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 1994-01-27 | Traditional | PDF ↗ |
| K934257 | U-TROL LIQUID URINE DIPSTICK CONTROL | P.T. Meditrol | 1993-11-26 | Traditional | PDF ↗ |
| K931467 | CHEK-STIX CONTROL STRIPS FOR URINALYSIS | Heraeus Kulzer, Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K902699 | SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) | Actio, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K891286 | BIOTROL CHEMISTRY URINE CONTROL | Biotrol, USA, Inc. | 1989-04-10 | Traditional | PDF ↗ |
| K890577 | KENLOR LIQUID URINE CONTROL | Kenlor Industries, Inc. | 1989-03-09 | Traditional | PDF ↗ |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | Fisher Scientific Co., LLC | 1989-03-08 | Traditional | PDF ↗ |
| K884424 | LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) | Bio-Rad | 1988-12-15 | Traditional | PDF ↗ |
| K880496 | LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) | Bio-Rad | 1988-03-16 | Traditional | PDF ↗ |
| K880495 | LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) | Bio-Rad | 1988-03-15 | Traditional | PDF ↗ |
| K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL | Quantimetrix Medical Industries | 1988-01-21 | Traditional | PDF ↗ |
| K863127 | TESTPACK ACUTE HCG URINGE CONTROLS | Abbott Laboratories | 1986-09-15 | Traditional | PDF ↗ |
| K861756 | V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II | Texas Immunology, Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K853603 | CANTROL URINE DIPSTICK CONTROL TWO LEVELS | Canyon Diagnostics, Inc. | 1985-10-08 | Traditional | PDF ↗ |
| K852295 | UROL-GUANT | Dimension Diagnostics | 1985-07-22 | Traditional | PDF ↗ |
| K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | Icl Scientific | 1984-10-05 | Traditional | PDF ↗ |
| K842366 | OXALATE URINE CONTROLS NORMAL & ELEVAT | Sigma Chemical Co. | 1984-09-12 | Traditional | PDF ↗ |
| K840848 | BIOSURE | Helena Laboratories | 1984-05-01 | Traditional | PDF ↗ |
| K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS | Biodiagnostic Intl | 1984-04-04 | Traditional | PDF ↗ |
| K832713 | IRI SPEC URINALYSIS CONTROL | Intl. Remote Imaging Systems | 1983-12-22 | Traditional | PDF ↗ |
| K831526 | URINE TOTAL PROTEIN CONTROL | Quantimetrix Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K831994 | BIOCHECK POSITIVE URINE CONTROL | Helena Laboratories | 1983-08-08 | Traditional | PDF ↗ |
| K830834 | NEGATIVE URINE CONTROL | Helena Laboratories | 1983-04-12 | Traditional | PDF ↗ |
| K822540 | COUNT-10 TROL | Texas Immunology, Inc. | 1982-10-08 | Traditional | PDF ↗ |
| K810917 | KOVA TROL I HUMAN URINE (DRIED) | Icl Scientific | 1981-04-14 | Traditional | PDF ↗ |
| K792374 | QUANTITATIVE CONTROL URINE I (HUMAN) | Environmental Chemical Specialties | 1979-12-06 | Traditional | PDF ↗ |
| K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) | Environmental Chemical Specialties | 1979-12-06 | Traditional | PDF ↗ |
| K781961 | CONTROL STRIP FOR VISUAL URINALYSIS | Miles Laboratories, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781691 | CHEMSTRIP CONTROL | Boehringer Mannheim Corp. | 1978-12-20 | Traditional | PDF ↗ |
| K780802 | ARMTROL AND FERMTROL | Biotron , Ltd. | 1978-06-13 | Traditional | PDF ↗ |
| K780482 | KOVA TROL III | Icl Scientific | 1978-05-03 | Traditional | PDF ↗ |
| K771713 | TEK-CHEK-2 | Miles Laboratories, Inc. | 1977-10-18 | Traditional | PDF ↗ |
| K770390 | URINALYSIS PROFICIENCY | Miles Laboratories, Inc. | 1977-05-03 | Traditional | PDF ↗ |
| K760863 | PRODUCT #K3002 KETOTROL-N(URINE CONTROL) | Sigma Chemical Co. | 1976-11-02 | Traditional | PDF ↗ |
Product code JJW · Class I · Clinical Chemistry. Data: openFDA.