Urine Total Protein Control
FDA 510(k) K831526 · Quantimetrix Corp.
510(k) numberK831526
Submission
- Device name
- Urine Total Protein Control
- Applicant
- Quantimetrix Corp.
Mchenry, IL, US - Received
- May 12, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJW – Urinalysis Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170091 | UA-Cellular CompleteJJW · Traditional | Streck | 02/09/2017SE |
| K142262 | Aution Check PlusJJW · Traditional | Quantimetrix Corp. | 04/10/2015SE |
| K131444 | Ua-Cellular CompleteJJW · Traditional | Streck | 01/29/2014SE |
| K110846 | Randox Urinalysis Controls, Levels 1 and 2JJW · Traditional | Randox Laboratories Limited | 09/30/2011SE |
| K103387 | Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip…JJW · Traditional | ACON Laboratories, Inc. | 02/02/2011SE |
| K081908 | Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2JJW · Traditional | Cliniqa Corporation | 01/16/2009SE |
| K072640 | Irispec,Ca/Cb/CcJJW · Abbreviated | Iris Diagnostics | 12/21/2007SE |
| K070848 | Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435XJJW · Traditional | Bio-Rad, Diagnostics Grp. | 04/25/2007SE |
| K052242 | Advia Chemistry Microalbumin ControlsJJW · Abbreviated | Bayer Healthcare, LLC | 10/03/2005SE |
| K043266 | Randox Urine ControlsJJW · Traditional | Randox Laboratories, Ltd. | 02/15/2005SE |
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| K152117 | Dropper hsCRP High Sensitivity CRP ControlJJX · Traditional | 04/21/2016SE |
| K142262 | Aution Check PlusJJW · Traditional | 04/10/2015SE |
| K113177 | Complete D 25-OH Vitamin D ControlJJX · Traditional | 05/10/2012SE |
| K103744 | Dropper A1C Diabetes ControlJJX · Traditional | 05/12/2011SE |
| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | 10/30/2006SE |
| K062751 | Modification to Quantimetrix Cardiasure Cardiac MarkerJJT · Special | 10/03/2006SE |
| K060417 | Modification to Quantimetrix Urine Drugs of Abuse ControlDIF · Special | 03/21/2006SE |
| K032791 | Glycohemosure HBA1C ControlGGM · Traditional | 10/30/2003SE |
| K030826 | Preciset Dat AmphetamineDIJ · Traditional | 04/03/2003SE |
| K021393 | Preciset Dat PlusDKB · Traditional | 06/13/2002SE |
Questions and answers
When was Urine Total Protein Control cleared by the FDA?
Urine Total Protein Control (K831526) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 92 days after the submission was received.
What is the product code of K831526?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.