Cliniqa Liquid QC Tumor Marker Control Level 1, Level 2, Level 3, and Tri Level
FDA 510(k) K030705 · Cliniqa Corporation
510(k) numberK030705
Submission
- Device name
- Cliniqa Liquid QC Tumor Marker Control Level 1, Level 2, Level 3, and Tri Level
- Applicant
- Cliniqa Corporation
Fallbrook, CA, US - Received
- March 6, 2003
- Decision date
- March 26, 2003
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K083554 | Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3JJY · Traditional | 04/21/2009SE |
| 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 |
Questions and answers
When was Cliniqa Liquid QC Tumor Marker Control Level 1, Level 2, Level 3, and Tri Level cleared by the FDA?
Cliniqa Liquid QC Tumor Marker Control Level 1, Level 2, Level 3, and Tri Level (K030705) received a 510(k) decision of Substantially Equivalent on March 26, 2003, 20 days after the submission was received.
What is the product code of K030705?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.