510(k) K103387
- Device
- MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
- Applicant
- ACON LABORATORIES, INC.
- 510(k) number
- K103387
- Product code
- JJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-02-02
- Date received
- 2010-11-18
- Regulation
- 862.1660
- Classification name
- Urinalysis Controls (assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD LENART
- Address
- 10125 Mesa Rim Rd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3010939897
- 3003646592
- 9615507
- 2432235
- 3009711478
- 2020715
- 3010127294
- 3009448641
- 3004493545
- 1649661
- 2085064
- 1616487
- 9611444
- 3003951180
- 9681576
- 3010421384
- 1219029
- 2085402
- 2084170
- 3010891909
- 2084025
- 1832816
- 3002637618
- 1832216
- 9613959
- 1827821
- 3010152370
- 1061932
- 3003917514
- 3007701696
- 2016706
- 2050010
- 3011310576
- 2531491
- 3003741796
- 2027370
Source Documents#
Other 510(k) Records For Product Code JJW #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary