Contrex Plus Low Control Solution
FDA 510(k) K100747 · Apex BioTechnology Corp.
510(k) numberK100747
Submission
- Device name
- Contrex Plus Low Control Solution
- Applicant
- Apex BioTechnology Corp.
Hsinchu, TW - Received
- March 16, 2010
- Decision date
- April 14, 2010
- 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 |
|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring SystemPTC · Traditional | 04/04/2025SE |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring SystemNBW · Special | 12/21/2022SE |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNBW · Special | 11/04/2022SE |
| K212140 | GlucoSure Link Blood Glucose Monitoring SystemNBW · Traditional | 08/25/2022SE |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 04/06/2022SE |
| K213887 | GAL-1A Plus Blood Glucose Monitoring SystemNBW · Special | 03/29/2022SE |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 10/15/2021SE |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring SystemNBW · Special | 09/15/2021SE |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | 12/18/2018SE |
| K182992 | BGM014 Blood Glucose Monitoring SystemNBW · Special | 11/28/2018SE |
Questions and answers
When was Contrex Plus Low Control Solution cleared by the FDA?
Contrex Plus Low Control Solution (K100747) received a 510(k) decision of Substantially Equivalent on April 14, 2010, 29 days after the submission was received.
What is the product code of K100747?
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.