FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
K Number: K151529
·
Decision Feb 11, 2016
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
87
Applicant Total
32
Review Days
248
Basic Information
- Device Name
- Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
- K Number
- K151529
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Date Received
- June 8, 2015
- Decision Date
- February 11, 2016
- Product Code
- CDZ
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDZ), ordered by most recent decision date.
IDS-iSYS Free Testosterone
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Access SHBG
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Access Testosterone
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elecsys Testosterone II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON Testosterone xt
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACTIVE® Free Testosterone RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by SIEMENS HEALTHCARE DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K162399 | Atellica CH Magnesium (Mg) | Jan 19, 2017 | Substantially Equivalent |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | Sep 7, 2016 | Substantially Equivalent |
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Apr 27, 2016 | Substantially Equivalent |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Mar 3, 2016 | Substantially Equivalent |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M) | Dec 22, 2015 | Substantially Equivalent |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Dec 18, 2015 | Substantially Equivalent |
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator | Dec 11, 2015 | Substantially Equivalent |
| K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive | Oct 23, 2015 | Substantially Equivalent |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Jul 17, 2015 | Substantially Equivalent |
| K150403 | ADVIA Centaur TSH3-Ultra | May 1, 2015 | Substantially Equivalent |