Lifescan Onetouch Ultra Control Solution
FDA 510(k) K022769 · Bionostics, Inc.
510(k) numberK022769
Submission
- Device name
- Lifescan Onetouch Ultra Control Solution
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- August 21, 2002
- Decision date
- November 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5JJX · Traditional | Roche Diagnostics | 04/04/2017SE |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5JJX · Traditional | Roche Diagnostics | 01/12/2017SE |
| K162514 | Multichem A1cJJX · Abbreviated | Technopath Manufacturing | 10/26/2016SE |
| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | Aalto Scientific, Ltd. | 08/10/2016SE |
| K161526 | LIAISON CMV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161522 | LIAISON EBV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | Immunodiagnostic Systems , Ltd. | 05/17/2016SE |
| K152117 | Dropper hsCRP High Sensitivity CRP ControlJJX · Traditional | Quantimetrix Corporation | 04/21/2016SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | Bayer Healthcare | 09/23/2015SE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/17/2015SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131136 | Glucose Meter-Check Solution for TaidocJJX · Traditional | 05/31/2013SE |
| K123851 | Glucose Meter-Check Solution for Roche Accu-ChekJJX · Traditional | 02/14/2013SE |
| K123966 | Glucose Meter-Check Solution for BayerJJX · Traditional | 01/25/2013SE |
| K113764 | Glucose Meter-Check Solution for InfopiaJJX · Traditional | 01/30/2012SE |
| K112352 | Glucose Meter-Check Control for Nipro TrueresultJJX · Traditional | 12/23/2011SE |
| K112356 | Glucose Meter-Check Control Solution for Agamatrix WavesenseJJX · Traditional | 09/19/2011SE |
| K103553 | Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionJJX · Traditional | 02/10/2011SE |
| K101831 | Enterix Insurefit Fob Controls, Model 16800OSL · Traditional | 10/01/2010SE |
| K091914 | Omnis Health Embrace Glucose Control SolutionJJX · Traditional | 11/06/2009SE |
| K081478 | RNA Medical Glucose and B-Ketone Calibration Verification ControlsJJX · Traditional | 10/06/2008SE |
Questions and answers
When was Lifescan Onetouch Ultra Control Solution cleared by the FDA?
Lifescan Onetouch Ultra Control Solution (K022769) received a 510(k) decision of Substantially Equivalent on November 13, 2002, 84 days after the submission was received.
What is the product code of K022769?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.