FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
K Number: K100321
·
Decision Apr 12, 2011
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
25
Applicant Total
92
Review Days
432
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 LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
- K Number
- K100321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- February 4, 2010
- Decision Date
- April 12, 2011
- Product Code
- LTK
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LTK), ordered by most recent decision date.
Access OV Monitor
FDA 510(k)
FDA Class 2
·Immunology
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
FDA 510(k)
FDA Class 2
·Immunology
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
FDA 510(k)
FDA Class 2
·Immunology
ADVIA Centaur CA 125II
FDA 510(k)
FDA Class 2
·Immunology
Elecsys CA-125 II assay
FDA 510(k)
FDA Class 2
·Immunology
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
FDA 510(k)
FDA Class 2
·Immunology
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 |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Jun 15, 2015 | Substantially Equivalent |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Apr 13, 2015 | Substantially Equivalent |