FDA 510(k) Applications for Medical Device Product Code "JJW"
(Urinalysis Controls (Assayed And Unassayed))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103387 | ACON LABORATORIES, INC. | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL | 02/02/2011 |
| K052242 | BAYER HEALTHCARE LLC | ADVIA CHEMISTRY MICROALBUMIN CONTROLS | 10/03/2005 |
| K031231 | BIO-RAD | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS | 06/18/2003 |
| K000874 | BIO-RAD | URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 | 04/18/2000 |
| K042446 | BIO-RAD LABORATORIES, INC. | QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS | 11/02/2004 |
| K070848 | BIO-RAD, DIAGNOSTICS GRP. | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X | 04/25/2007 |
| K081908 | CLINIQA CORPORATION | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | 01/16/2009 |
| K992576 | CONSOLIDATED TECHNOLOGIES, INC. | URINE CHEMISTRY CONTROL, LEVEL 1 | 09/03/1999 |
| K992578 | CONSOLIDATED TECHNOLOGIES, INC. | URINE CHEMISTRY CONTROL, LEVEL 2 | 09/03/1999 |
| K972710 | HEMATRONIX, INC. | QUANTIFY(901) | 08/15/1997 |
| K072640 | IRIS DIAGNOSTICS | IRISPEC,CA/CB/CC | 12/21/2007 |
| K022085 | J & S MEDICAL ASSOC., INC. | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL | 07/25/2002 |
| K973451 | MEDICAL ANALYSIS SYSTEMS, INC. | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 | 09/29/1997 |
| K023928 | MEDICAL ANALYSIS SYSTEMS, INC. | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL | 12/11/2002 |
| K021155 | MEDICAL ANALYSIS SYSTEMS, INC. | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL | 04/29/2002 |
| K981933 | MEDICAL ANALYSIS SYSTEMS, INC. | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 | 06/29/1998 |
| K031441 | MEDICAL ANALYSIS SYSTEMS, INC. | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | 07/01/2003 |
| K991917 | METRIKA, INC. | OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET | 07/12/1999 |
| K142262 | QUANTIMETRIX CORP. | AUTION CHECK PLUS | 04/10/2015 |
| K110846 | RANDOX LABORATORIES LIMITED | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | 09/30/2011 |
| K043266 | RANDOX LABORATORIES, LTD. | RANDOX URINE CONTROLS | 02/15/2005 |
| K170091 | Streck | UA-Cellular Complete | 02/09/2017 |
| K131444 | Streck | UA-CELLULAR COMPLETE | 01/29/2014 |
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