It/If Control
FDA 510(k) K101863 · Sebia
510(k) numberK101863
Submission
- Device name
- It/If Control
- Applicant
- Sebia
Norcross, GA, US - Received
- July 2, 2010
- Decision date
- November 7, 2011
- 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 |
|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | 04/04/2024SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | 02/23/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | 11/18/2022SE |
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | 11/01/2019SE |
| K190851 | HYDRASHIFT 2/4 daratumumabCFF · Special | 05/02/2019SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | 12/14/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | 02/07/2018SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | 01/11/2018SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | 09/12/2017SE |
Questions and answers
When was It/If Control cleared by the FDA?
It/If Control (K101863) received a 510(k) decision of Substantially Equivalent on November 7, 2011, 493 days after the submission was received.
What is the product code of K101863?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.