JIS — Calibrator, Primary Class II
FDA product code JIS covers "Calibrator, Primary", 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
- JIS
- 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 |
|---|---|---|---|
| K122126 | randox laboratories limited | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | August 14, 2012 |
| K061251 | dade behring | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | May 31, 2006 |
| K060266 | dade behring | DIMENSION IRON CALIBRATOR | March 9, 2006 |
| K053104 | dade behring | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR | December 23, 2005 |
| K032697 | dade behring | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | November 7, 2003 |
| K032608 | gonotec gesellschaft fuer mess-und regeltechnik mb | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | October 21, 2003 |
| K032296 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS | August 13, 2003 |
| K030964 | instrumentation laboratory | CALIBRATION PLASMA LMW HEPARIN | June 6, 2003 |
| K030546 | denka seiken co | CRP (II) CALIBRATORS | June 2, 2003 |
| K030320 | wako chemicals usa | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON | April 11, 2003 |
| K022682 | randox laboratories | RANDOX C-REACTIVE PROTEIN CALIBRATOR | November 5, 2002 |
| K022901 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS | September 27, 2002 |
| K013126 | dade behring | N LP(A) STANDARD SY | November 9, 2001 |
| K012878 | thermo dma | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | October 16, 2001 |
| K011568 | randox laboratories | RANDOX LIPOPROTEIN | September 28, 2001 |
| K010696 | beckman coulter | BECKMAN COULTER DNASE B CALIBRATOR | May 10, 2001 |
| K003941 | roche diagnostics | ELECSYS HCG STAT CLASET II | January 25, 2001 |
| K003969 | roche diagnostics | ELECSYS CA 125 II CALSET | January 12, 2001 |
| K002760 | roche diagnostics | ELECSYS DHEA-S CALSET | October 5, 2000 |
| K002353 | roche diagnostics | ELECSYS CA 15-3 CALCHECK | August 10, 2000 |