JJW — Urinalysis Controls (Assayed And Unassayed) Class I
FDA Device Classification
Classification Details
- Product Code
- JJW
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K170091 | streck | UA-Cellular Complete | February 9, 2017 |
| K142262 | quantimetrix | AUTION CHECK PLUS | April 10, 2015 |
| K131444 | streck | UA-CELLULAR COMPLETE | January 29, 2014 |
| K110846 | randox laboratories limited | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | September 30, 2011 |
| K103387 | acon laboratories | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY | February 2, 2011 |
| K081908 | cliniqa corporation | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | January 16, 2009 |
| K072640 | iris diagnostics | IRISPEC,CA/CB/CC | December 21, 2007 |
| K070848 | bio-rad, diagnostics grp | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,43 | April 25, 2007 |
| K052242 | bayer healthcare | ADVIA CHEMISTRY MICROALBUMIN CONTROLS | October 3, 2005 |
| K043266 | randox laboratories | RANDOX URINE CONTROLS | February 15, 2005 |
| K042446 | bio-rad laboratories | QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS | November 2, 2004 |
| K031441 | medical analysis systems | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | July 1, 2003 |
| K031231 | bio-rad | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL L | June 18, 2003 |
| K023928 | medical analysis systems | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTRO | December 11, 2002 |
| K022085 | j and s medical assoc | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL | July 25, 2002 |
| K021155 | medical analysis systems | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL | April 29, 2002 |
| K000874 | bio-rad | URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 | April 18, 2000 |
| K992576 | consolidated technologies | URINE CHEMISTRY CONTROL, LEVEL 1 | September 3, 1999 |
| K992578 | consolidated technologies | URINE CHEMISTRY CONTROL, LEVEL 2 | September 3, 1999 |
| K991917 | metrika | OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET | July 12, 1999 |