ClearanceBrief
510(k) K151767 ยท JGS Electrode, Ion Specific, Sodium

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

ApplicantSiemens Healthcare Diagnostics, Inc., Newark DE, US
DecisionSubstantially Equivalent, Dec 11, 2015
ReceivedJun 30, 2015
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K151767

DateFirm and productCodeLinked 510(k)
Jun 25, 2025Siemens Healthcare Diagnostics, Inc.
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Open, Classified		 JJENone listed
Feb 7, 2024Siemens Healthcare Diagnostics, Inc.
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Open, Classified		 CFNNone listed
Nov 18, 2021Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Numb
Open, Classified		 JGSNone listed
May 13, 2021Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Open, Classified		 JGSNone listed
May 4, 2021Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Open, Classified		 JGSNone listed
Dec 2, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of
Terminated		 JGSNone listed
Feb 27, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Terminated		 JGSNone listed
Oct 11, 2019Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro
Terminated		 JGSNone listed
Sep 23, 2019Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer
Terminated		 JJENone listed
Jul 30, 2019Siemens Healthcare Diagnostics, Inc.
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Terminated		 JGSNone listed
Sep 26, 2018Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro d
Terminated		 JITNone listed
Jun 29, 2018Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated		 JJENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.