Liquichek Urine Chemistry Control
FDA 510(k) K121794 · Bio-Rad, Diagnostics Grp.
510(k) numberK121794
Submission
- Device name
- Liquichek Urine Chemistry Control
- Applicant
- Bio-Rad, Diagnostics Grp.
Irvine, CA, US - Received
- June 19, 2012
- Decision date
- July 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K070848 | Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435XJJW · Traditional | 04/25/2007SE |
Questions and answers
When was Liquichek Urine Chemistry Control cleared by the FDA?
Liquichek Urine Chemistry Control (K121794) received a 510(k) decision of Substantially Equivalent on July 11, 2012, 22 days after the submission was received.
What is the product code of K121794?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.