Liquichek Tumor Marker Control
FDA 510(k) K141073 · Bio-Rad Laboratories
510(k) numberK141073
Submission
- Device name
- Liquichek Tumor Marker Control
- Applicant
- Bio-Rad Laboratories
Irvine, CA, US - Received
- April 25, 2014
- Decision date
- June 23, 2014
- 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
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 |
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| K183446 | BioPlex 2200 Lyme TotalLSR · Traditional | 03/12/2019SE |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX · Traditional | 02/13/2019SE |
| K180577 | BioPlex 2200 25-OH Vitamin D KitMRG · Traditional | 06/22/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | 09/13/2017SE |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…PUQ · Traditional | 05/19/2017SE |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…LIP · Traditional | 05/11/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | 01/10/2017SE |
| K161687 | D-10 Hemoglobin A1c ProgramPDJ · Traditional | 10/14/2016SE |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level…PMN · Traditional | 05/10/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | 12/11/2015SE |
Questions and answers
When was Liquichek Tumor Marker Control cleared by the FDA?
Liquichek Tumor Marker Control (K141073) received a 510(k) decision of Substantially Equivalent on June 23, 2014, 59 days after the submission was received.
What is the product code of K141073?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.