FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K151767
·
Decision Dec 11, 2015
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
160
Applicant Total
32
Review Days
164
Basic Information
- Device Name
- 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
- K Number
- K151767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Date Received
- June 30, 2015
- Decision Date
- December 11, 2015
- Product Code
- JGS
- 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 |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | FDA class 2 | Clinical Chemistry |
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