UA-Cellular Complete
FDA 510(k) K170091 · Streck
510(k) numberK170091
Submission
- Device name
- UA-Cellular Complete
- Applicant
- Streck
La Vista, NE, US - Received
- January 10, 2017
- Decision date
- February 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K042446 | Quantify Control and Quantify Plus ControlsJJW · Traditional | Bio-Rad Laboratories, Inc. | 11/02/2004SE |
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| K231776 | Cell-Free DNA BCTQMA · Traditional | 07/26/2024SE |
| K231223 | MDx-Chex for BC-GNPMN · Traditional | 07/27/2023SE |
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| K212576 | MDx-Chex for BCID2PMN · Traditional | 01/19/2022SE |
| K160590 | XN CheckJPK · Traditional | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | 12/22/2016SE |
| K160586 | Xn-L CheckJPK · Traditional | 12/22/2016SE |
Questions and answers
When was UA-Cellular Complete cleared by the FDA?
UA-Cellular Complete (K170091) received a 510(k) decision of Substantially Equivalent on February 9, 2017, 30 days after the submission was received.
What is the product code of K170091?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.