JIT — Calibrator, Secondary Class II
FDA Device Classification
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 | April 26, 2017 |
| K170160 | abbott laboratories | Abbott ARCHITECT Free T3 | February 15, 2017 |
| K163546 | fujirebio diagnostics | Lumipulse G Progesterone-N Calibrators | January 13, 2017 |
| K163534 | fujirebio diagnostics | Lumipulse G FSH-N Calibrators | January 13, 2017 |
| K163521 | fujirebio diagnostics | Lumipulse G LH Calibrators | January 12, 2017 |
| K163544 | fujirebio diagnostics | Lumipulse G Prolactin | January 12, 2017 |
| K163078 | sekisui diagnostics p.e.i | DC-UIBC-CAL | December 8, 2016 |
| K163053 | fujirebio diagnostics | Lumipulse G E2-III Calibrators | December 1, 2016 |
| K162538 | siemens healthcare diagnostics | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal | November 17, 2016 |
| K160113 | tosoh bioscience | ST AIA-PACK hsE2 Calibrator Set | February 17, 2016 |
| K153417 | tosoh bioscience | ST AIA-PACK PROG III Calibrator Set | December 18, 2015 |
| K152526 | roche diagnostics | Elecsys Progesterone III CalSet | October 2, 2015 |
| K151566 | abbott laboratories | Abbott ARCHITECT Total T4 Calibrators | July 10, 2015 |
| K142985 | beckman coulter | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON Syst | February 26, 2015 |
| K143342 | roche diagnostics | Elecsys T-Uptake Calset | December 19, 2014 |
| K143144 | tosoh bioscience | ST AIA-PACK PROG II Calibrator Set | December 3, 2014 |
| K142181 | randox laboratories limited | RANDOX ALDOLASE CALIBRATION SERUM | September 18, 2014 |
| K142021 | roche diagnostics | Elecsys Estradiol III CalSet | August 12, 2014 |
| K133751 | diamond diagnostics | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | August 8, 2014 |