DeviceClearance

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— 510(k) K151767

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K151767 for 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, Substantially Equivalent on 2015-12-11. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code JGS
Device class
Class 2
Regulation
21 CFR 862.1665
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JGS

product code JGS
Malfunction
535
Total
535

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K151767

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151767.

Data sourced from openFDA. This site is unofficial and independent of the FDA.