510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151767Substantially Equivalent

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

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151767 is the FDA 510(k) clearance record 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, a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show 12 recalls naming K151767.

Clearance record

Decision date
Received
(164 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr., P.O. Box 6101 Ms 514, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JGS

Trailing 12 months
1 clearance under product code JGS in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JGS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260