FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
K Number: K140790
·
Decision Jun 15, 2015
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
92
Review Days
441
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K Number
- K140790
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- March 31, 2014
- Decision Date
- June 15, 2015
- Product Code
- JIX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIX), ordered by most recent decision date.
VITROS Chemistry Products Calibrator Kit 3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYSTEM CALIBRATER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Siemens Healthcare Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Apr 25, 2025 | Substantially Equivalent |
| K162977 | ADVIA 2120i, ADVIA 2120 | Aug 11, 2017 | Substantially Equivalent |
| K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Mar 16, 2017 | Substantially Equivalent |
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) | Mar 9, 2017 | Substantially Equivalent |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Nov 17, 2016 | Substantially Equivalent |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls | Sep 30, 2016 | Substantially Equivalent |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Nov 4, 2015 | Substantially Equivalent |
| K143720 | Dimension Vista MMB Assay | Sep 18, 2015 | Substantially Equivalent |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Apr 13, 2015 | Substantially Equivalent |
| K143639 | IMMULITE 2000 CEA Calibration Verification Material | Jan 23, 2015 | Substantially Equivalent |