Validate (R) GC3 Calibration Verification / Linearity Test Kit
FDA 510(k) K110880 · Maine Standards Company, LLC
510(k) numberK110880
Submission
- Device name
- Validate (R) GC3 Calibration Verification / Linearity Test Kit
- Applicant
- Maine Standards Company, LLC
Windham, ME, US - Received
- March 30, 2011
- Decision date
- July 5, 2011
- 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 |
|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test KitGGN · Traditional | 06/21/2017SE |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test KitGGN · Traditional | 03/16/2017SE |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitGGN · Traditional | 01/05/2017SE |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test KitGGN · Traditional | 06/03/2016SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | 04/30/2015SE |
| K133550 | Validate Ferritin Calibration Verification/ Linearity Test KitJJX · Traditional | 02/05/2014SE |
| K123127 | Validate Psa Calibration Verification/ Linearity Test Kit Model 406JJX · Traditional | 06/14/2013SE |
| K113524 | Validate Vit D Calibration Verification/ Linearity Test KitJJX · Traditional | 01/27/2012SE |
| K103271 | MSC Lipid ControlJJY · Traditional | 01/25/2011SE |
| K091225 | Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetJJY · Traditional | 06/25/2009SE |
Questions and answers
When was Validate (R) GC3 Calibration Verification / Linearity Test Kit cleared by the FDA?
Validate (R) GC3 Calibration Verification / Linearity Test Kit (K110880) received a 510(k) decision of Substantially Equivalent on July 5, 2011, 97 days after the submission was received.
What is the product code of K110880?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.