Immulite 2000 DHEA-SO4; Third Generation TSH and Intact PTH Calibration Verification Material
FDA 510(k) K140258 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK140258
Submission
- Device name
- Immulite 2000 DHEA-SO4; Third Generation TSH and Intact PTH Calibration Verification Material
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- February 3, 2014
- Decision date
- March 5, 2014
- 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 |
| 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 |
|---|---|---|
| K253528 | Atellica IM CA 19-9 IINIG · Traditional | 08/10/2026SE |
| K261364 | Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional | 07/24/2026SE |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | 02/27/2026SE |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional | 02/06/2026SE |
| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | 01/05/2026SE |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL · Traditional | 12/04/2025SE |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | 10/17/2025SE |
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | 06/20/2025SE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | 04/25/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | 12/04/2024SE |
Questions and answers
When was Immulite 2000 DHEA-SO4; Third Generation TSH and Intact PTH Calibration Verification Material cleared by the FDA?
Immulite 2000 DHEA-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (K140258) received a 510(k) decision of Substantially Equivalent on March 5, 2014, 30 days after the submission was received.
What is the product code of K140258?
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.