Multichem A1c
FDA 510(k) K162514 · Technopath Manufacturing
510(k) numberK162514
Submission
- Device name
- Multichem A1c
- Applicant
- Technopath Manufacturing
Ballina, IE - Received
- September 8, 2016
- Decision date
- October 26, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
| K150955 | Elecsys Progesterone III Cal Check 5JJX · Traditional | Roche Diagnostics | 05/01/2015SE |
Questions and answers
When was Multichem A1c cleared by the FDA?
Multichem A1c (K162514) received a 510(k) decision of Substantially Equivalent on October 26, 2016, 48 days after the submission was received.
What is the product code of K162514?
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.