Product code JIT
- Device name
- Calibrator, Secondary
- 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 |
|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017-05-16 |
| K170938 | CalSet IGF-1 | Roche Diagnostics | 2017-04-26 |
| K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | 2017-02-15 |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| K163078 | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016-12-01 |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics | 2016-11-17 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | 2016-02-17 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | 2015-12-18 |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | 2015-10-02 |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | 2015-07-10 |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Beckman Coulter, Inc. | 2015-02-26 |
| K143342 | Elecsys T-Uptake Calset | Roche Diagnostics | 2014-12-19 |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | 2014-12-03 |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | Randox Laboratories Limited | 2014-09-18 |
| K142021 | Elecsys Estradiol III CalSet | Roche Diagnostics | 2014-08-12 |
| K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | Diamond Diagnostics, Inc. | 2014-08-08 |
| K141728 | ACE CALIBRATOR | SENTINEL CH. SpA | 2014-07-28 |
| K141374 | BICARBONATE CALIBRATOR | Beckman Coulter Ireland, Inc. | 2014-06-30 |
| K140112 | CA 125 II CALSET II | Roche Diagnostics | 2014-06-06 |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | Tosoh Bioscience, Inc. | 2014-04-10 |
| K130603 | PATHFAST CTNL CALIBRATORS | Mitsubishi Chemical Medience Corporation | 2014-03-27 |
| K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS | Biokit, S.A. | 2013-12-19 |
| K130628 | PATHFAST CK-MB-II CALIBRATORS | Mitsubishi Chemical Medience Corporation | 2013-10-04 |
| K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET | Diazyme Laboratories | 2013-06-26 |
| K130698 | DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) | Siemens Healthcare Diagnostics | 2013-04-05 |
| K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL | Elitechgroup | 2013-02-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08058056685391 | Cystatin C Calibrators | SENTINEL CH. SPA | 2025-09-16 |
| 14562185400400 | CL AIA-PACK FSH ADJUSTER SET | TOSOH CORPORATION | 2025-09-01 |
| 14562185399728 | CL AIA-PACK LH ADJUSTER SET | TOSOH CORPORATION | 2025-09-01 |
| 14562185399674 | CL AIA-PACK Progesterone ADJUSTER SET | TOSOH CORPORATION | 2025-09-01 |
| 14562185395454 | CL AIA-PACK T3 ADJUSTER SET | TOSOH CORPORATION | 2025-09-01 |
| 14560189216638 | CL AIA-PACK hs-E2 ADJUSTER SET | TOSOH CORPORATION | 2025-09-01 |
| 14560189216331 | CL AIA-PACK Prolactin II ADJUSTER SET | TOSOH CORPORATION | 2025-09-01 |
| 10758750035069 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-09-18 |
| 10758750034628 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-09-18 |
| 10758750034918 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-04-25 |
| 10758750032716 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-01-20 |
| 15099590702137 | Access Unconjugated Estriol Calibrators | Beckman Coulter, Inc. | 2023-01-10 |
| 07613336166345 | CalSet beta-Amyloid (1-42) II | Roche Diagnostics GmbH | 2022-12-13 |
| 14987481100999 | NEFA Standard Solution | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2020-10-23 |
| 20816467020345 | FastPack® IP SHBG | QUALIGEN INC. | 2019-03-15 |
| 10816467020348 | FastPack® IP SHBG | QUALIGEN INC. | 2019-02-01 |
| 08426950793168 | QUANTA Flash® HMGCR Calibrators | INOVA DIAGNOSTICS, INC. | 2018-10-31 |
| 08426950729938 | QUANTA Flash® M2 (MIT3) Calibrators | INOVA DIAGNOSTICS, INC. | 2018-01-26 |
| 08426950766988 | QUANTA Flash® Lkm-1 Calibrators | INOVA DIAGNOSTICS, INC. | 2017-12-15 |
| 08426950596264 | QUANTA Flash® SS-B Calibrators | INOVA DIAGNOSTICS, INC. | 2017-08-28 |
| 08426950724490 | QUANTA Flash® Scl-70 Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950622185 | QUANTA Flash® CCP3 Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950601913 | QUANTA Flash® dsDNA Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950597049 | QUANTA Flash® Ro60 Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950596653 | QUANTA Flash® Ro52 Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950596028 | QUANTA Flash® Sm Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595724 | QUANTA Flash® Jo-1 Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595717 | QUANTA Flash® RNP Calibrators | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08058056681768 | ACE Calibrator | SENTINEL CH. SPA | 2016-07-29 |
| 00380740001254 | ARCHITECT | Abbott GmbH | 2016-06-06 |