Product code JIS
- Device name
- Calibrator, Primary
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1150
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | Randox Laboratories Limited | 2012-08-14 |
| K061251 | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | Dade Behring, Inc. | 2006-05-31 |
| K060266 | DIMENSION IRON CALIBRATOR | Dade Behring, Inc. | 2006-03-09 |
| K053104 | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR | Dade Behring, Inc. | 2005-12-23 |
| K032697 | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | Dade Behring, Inc. | 2003-11-07 |
| K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 2003-10-21 |
| K032296 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 2003-08-13 |
| K030964 | CALIBRATION PLASMA LMW HEPARIN | Instrumentation Laboratory CO | 2003-06-06 |
| K030546 | CRP (II) CALIBRATORS | Denka Seiken Co., Ltd. | 2003-06-02 |
| K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET | Wako Chemicals USA, Inc. | 2003-04-11 |
| K022682 | RANDOX C-REACTIVE PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2002-11-05 |
| K022901 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics | 2002-09-27 |
| K013126 | N LP(A) STANDARD SY | Dade Behring, Inc. | 2001-11-09 |
| K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | Thermo Dma, Inc. | 2001-10-16 |
| K011568 | RANDOX LIPOPROTEIN | Randox Laboratories, Ltd. | 2001-09-28 |
| K010696 | BECKMAN COULTER DNASE B CALIBRATOR | Beckman Coulter, Inc. | 2001-05-10 |
| K003941 | ELECSYS HCG STAT CLASET II | Roche Diagnostics Corp. | 2001-01-25 |
| K003969 | ELECSYS CA 125 II CALSET | Roche Diagnostics Corp. | 2001-01-12 |
| K002760 | ELECSYS DHEA-S CALSET | Roche Diagnostics Corp. | 2000-10-05 |
| K002353 | ELECSYS CA 15-3 CALCHECK | Roche Diagnostics Corp. | 2000-08-10 |
| K001906 | ELECSYS INSULIN CALSET | Roche Diagnostics Corp. | 2000-07-13 |
| K001004 | WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR | Wako Chemicals USA, Inc. | 2000-06-01 |
| K001005 | WAKO HDL-C/LDL-C CALIBRATOR | Wako Chemicals USA, Inc. | 2000-06-01 |
| K001002 | WAKO LIPASE CALIBRATOR | Wako Chemicals USA, Inc. | 2000-05-24 |
| K000331 | SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-10 |
| K994169 | SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-03 |
| K994168 | SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-03 |
| K994114 | DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR | Dade Behring, Inc. | 2000-01-20 |
| K994325 | SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-01-12 |
| K994145 | VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 1999-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10758750035373 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2025-05-20 |
| 00630414615097 | Atellica CH Billirubin Calibrator (BILI CAL) | Siemens Healthcare Diagnostics Inc. | 2024-04-03 |
| 00630414611297 | Atellica CH RCRP Cal | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 10758750034635 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-01-20 |
| 00630414610863 | Atellica CH HDLC CAL | Siemens Healthcare Diagnostics Inc. | 2022-07-08 |
| 00380740131357 | Alinity | Abbott GmbH | 2020-11-06 |
| 14987481164564 | L-Type HDL-C Reagent 1 | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2020-10-23 |
| 14987481164557 | HDL-C/LDL-C Calibrator | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2020-10-23 |
| 14987481164571 | L-Type HDL-C Reagent 2 | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2020-10-23 |
| 00630414285009 | N LP(a) Standard SY | Siemens Healthcare Diagnostics Products GmbH | 2020-10-12 |
| 00630414293578 | Atellica IM Calibrator E | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00380740156435 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00630414234489 | Atellica IM VitD | Siemens Healthcare Diagnostics Inc. | 2018-09-29 |
| 00380740119416 | ARCHITECT | Abbott GmbH | 2017-01-31 |
| 00380740119409 | ARCHITECT | Abbott GmbH | 2016-12-31 |
| 00380740119393 | ARCHITECT | Abbott GmbH | 2016-12-31 |
| 00380740054267 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740000356 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740011185 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740011178 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740010485 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740010478 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740010454 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740003654 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740003296 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740003265 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740008994 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740008987 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740008970 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740008963 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |