Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435X
FDA 510(k) K070848 · Bio-Rad, Diagnostics Grp.
510(k) numberK070848
Submission
- Device name
- Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435X
- Applicant
- Bio-Rad, Diagnostics Grp.
Irvine, CA, US - Received
- March 28, 2007
- Decision date
- April 25, 2007
- 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
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| 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 |
| 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 |
More from Bio-Rad Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121794 | Liquichek Urine Chemistry ControlJJY · Traditional | 07/11/2012SE |
| K100727 | Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3…JJY · Traditional | 09/14/2010SE |
| K072835 | Liquichek Microalbumin Control Level 1, Level 2, Control MinipakJJY · Traditional | 12/11/2007SE |
| K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCDIF · Traditional | 12/11/2007SE |
| K071319 | I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01…GGN · Traditional | 06/26/2007SE |
Questions and answers
When was Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435X cleared by the FDA?
Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435X (K070848) received a 510(k) decision of Substantially Equivalent on April 25, 2007, 28 days after the submission was received.
What is the product code of K070848?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.