JIT — Calibrator, Secondary Class II
FDA product code JIT covers "Calibrator, Secondary", a Class II medical device regulated under 21 CFR 862.1150. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIT
- Device Class
- Class II
- Regulation Number
- 862.1150
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171168 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Insulin Calibrators | May 16, 2017 |
| K170938 | Roche Diagnostics | CalSet IGF-1 | Apr 26, 2017 |
| K170160 | Abbott Laboratories | Abbott ARCHITECT Free T3 | Feb 15, 2017 |
| K163534 | Fujirebio Diagnostics | Lumipulse G FSH-N Calibrators | Jan 13, 2017 |
| K163546 | Fujirebio Diagnostics | Lumipulse G Progesterone-N Calibrators | Jan 13, 2017 |
| K163521 | Fujirebio Diagnostics | Lumipulse G LH Calibrators | Jan 12, 2017 |
| K163544 | Fujirebio Diagnostics | Lumipulse G Prolactin | Jan 12, 2017 |
| K163078 | Sekisui Diagnostics P.E.I | DC-UIBC-CAL | Dec 8, 2016 |
| K163053 | Fujirebio Diagnostics | Lumipulse G E2-III Calibrators | Dec 1, 2016 |
| K162538 | Siemens Healthcare Diagnostics | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal | Nov 17, 2016 |
| K160113 | Tosoh Bioscience | ST AIA-PACK hsE2 Calibrator Set | Feb 17, 2016 |
| K153417 | Tosoh Bioscience | ST AIA-PACK PROG III Calibrator Set | Dec 18, 2015 |
| K152526 | Roche Diagnostics | Elecsys Progesterone III CalSet | Oct 2, 2015 |
| K151566 | Abbott Laboratories | Abbott ARCHITECT Total T4 Calibrators | Jul 10, 2015 |
| K142985 | Beckman Coulter | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON Syst | Feb 26, 2015 |
| K143342 | Roche Diagnostics | Elecsys T-Uptake Calset | Dec 19, 2014 |
| K143144 | Tosoh Bioscience | ST AIA-PACK PROG II Calibrator Set | Dec 3, 2014 |
| K142181 | Randox Laboratories Limited | RANDOX ALDOLASE CALIBRATION SERUM | Sep 18, 2014 |
| K142021 | Roche Diagnostics | Elecsys Estradiol III CalSet | Aug 12, 2014 |
| K133751 | Diamond Diagnostics | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | Aug 8, 2014 |