Product code JJW
- Device name
- Urinalysis Controls (Assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1660
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170091 | UA-Cellular Complete | Streck | 2017-02-09 |
| K142262 | AUTION CHECK PLUS | Quantimetrix Corp. | 2015-04-10 |
| K131444 | UA-CELLULAR COMPLETE | Streck | 2014-01-29 |
| K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | Randox Laboratories Limited | 2011-09-30 |
| K103387 | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL | ACON Laboratories, Inc. | 2011-02-02 |
| K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | Cliniqa Corporation | 2009-01-16 |
| K072640 | IRISPEC,CA/CB/CC | Iris Diagnostics | 2007-12-21 |
| K070848 | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X | Bio-Rad, Diagnostics Grp. | 2007-04-25 |
| K052242 | ADVIA CHEMISTRY MICROALBUMIN CONTROLS | Bayer Healthcare, LLC | 2005-10-03 |
| K043266 | RANDOX URINE CONTROLS | Randox Laboratories, Ltd. | 2005-02-15 |
| K042446 | QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS | Bio-Rad Laboratories, Inc. | 2004-11-02 |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | Medical Analysis Systems, Inc. | 2003-07-01 |
| K031231 | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS | Bio-Rad | 2003-06-18 |
| K023928 | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 2002-12-11 |
| K022085 | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL | J & S Medical Assoc., Inc. | 2002-07-25 |
| K021155 | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 2002-04-29 |
| K000874 | URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 | Bio-Rad | 2000-04-18 |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | Consolidated Technologies, Inc. | 1999-09-03 |
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | Consolidated Technologies, Inc. | 1999-09-03 |
| K991917 | OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET | Metrika, Inc. | 1999-07-12 |
| K981933 | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 | Medical Analysis Systems, Inc. | 1998-06-29 |
| K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 | Medical Analysis Systems, Inc. | 1997-09-29 |
| K972710 | QUANTIFY(901) | Hematronix, Inc. | 1997-08-15 |
| K952840 | KENLOR LIQUID TOTAL URINE CONTROL | Kenlor Industries, Inc. | 1995-07-19 |
| K945913 | IRISPEC URINE CHEMISTRY CONTROL PART A AND B | International Remote Imaging Systems | 1995-04-05 |
| K943780 | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) | Heraeus Kulzer, Inc. | 1994-10-31 |
| K942853 | KOVA LIQUA-TROL | Hycor Biomedical, Inc. | 1994-10-04 |
| K935062 | MAS LIQUID URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 1994-01-27 |
| K934257 | U-TROL LIQUID URINE DIPSTICK CONTROL | P.T. Meditrol | 1993-11-26 |
| K931467 | CHEK-STIX CONTROL STRIPS FOR URINALYSIS | Heraeus Kulzer, Inc. | 1993-05-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06935740751605 | Maintenance Agent | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751612 | SG Control | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751629 | Color Control | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751636 | Turbidity Control | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751643 | SG Calibrator | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751650 | Turbidity Calibrator | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751667 | Mutiple Control for SG | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751582 | Urinalysis Control | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 50885380126107 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-06-10 |
| 50885380126091 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-06-10 |
| 00682607200672 | Mission Liquid Urine Controls | Acon Laboratories, Inc. | 2025-04-17 |
| 20612479214969 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-16 |
| 20612479214952 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-16 |
| 20612479214945 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-16 |
| 20612479214938 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-16 |
| 10885380151934 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-24 |
| 10885380151927 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-16 |
| 10885380151910 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-16 |
| 10885380151903 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-16 |
| 10858512007003 | NA | ALTA DIAGNOSTICS INC | 2019-03-29 |
| 10858512007126 | NA | ALTA DIAGNOSTICS INC | 2019-03-29 |
| 10858512007119 | NA | ALTA DIAGNOSTICS INC | 2019-03-29 |
| 10858512007096 | NA | ALTA DIAGNOSTICS INC | 2019-03-29 |
| 10858512007089 | NA | ALTA DIAGNOSTICS INC | 2019-03-29 |
| 10858512007041 | NA | ALTA DIAGNOSTICS INC | 2019-03-29 |
| 10858512007010 | NA | ALTA DIAGNOSTICS INC | 2019-03-29 |
| 00612479197411 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-03-18 |
| 00612479197435 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-03-18 |
| 04987562408535 | UF ll CALIBRATOR | SYSMEX CORPORATION | 2017-10-06 |
| 00628063400829 | MICROALBUMIN Urine Level 1 and 2 | Sekisui Diagnostics, LLC | 2016-09-20 |