Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3
FDA 510(k) K083554 · Cliniqa Corporation
510(k) numberK083554
Submission
- Device name
- Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3
- Applicant
- Cliniqa Corporation
San Marcos, CA, US - Received
- December 1, 2008
- Decision date
- April 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code JJY
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|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| 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 |
|---|---|---|
| K120900 | I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional | 05/31/2013SE |
| K121237 | Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG…JJX · Traditional | 05/18/2012SE |
| K081908 | Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2JJW · Traditional | 01/16/2009SE |
| K082107 | Cliniqa Liquid QC Urine Chemistry Controls, Levels 1 and 2JJY · Traditional | 09/17/2008SE |
| K080973 | Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker…JJY · Traditional | 06/02/2008SE |
| K070741 | Cliniqa Liquid QC Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3JJY · Traditional | 05/04/2007SE |
| K062916 | Cliniqa Liquid QC Cardiac Marker Control SP, Levels 1,2, &3JJY · Traditional | 10/23/2006SE |
| K061182 | Cliniqa Liquid QC Lipid Control Levels 1 & 2;LINICAL Lipid Calibration Verifiers Levels…JJY · Traditional | 05/25/2006SE |
| K060322 | Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry…JIT · Traditional | 03/21/2006SE |
| K052679 | Cliniqa Liquid QC Bilirubin Controls Levels 1, 2 & 3; Cliniqa Linical Bilirubin…JJX · Traditional | 11/18/2005SE |
Questions and answers
When was Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3 cleared by the FDA?
Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3 (K083554) received a 510(k) decision of Substantially Equivalent on April 21, 2009, 141 days after the submission was received.
What is the product code of K083554?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.