CREATINE KINASE (CK) TEST ITEM #65411

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CK-MB ASSAY, CATALOGUE NUMBER 317-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QuikLYTE IMT (Na+/K+/Cl-)

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·7 products·🇺🇸 United States

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Latitude™ NXT Patient Management System (INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent

Mueller Hinton II Agar + 5% Horse Blood + 20 mg/l NAD

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·GRASO Zenon Sobiecki·2 devices

SIGMA PROCEDURE NO. 333-UV

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ON.SITE ALCOHOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT ST SERUM ETHYL ALCOHOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT ST URINE ETHYL ALCOHOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAICHEM(TM) ALCOHOL REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMDS(TM) ALCOHOL TESTPACKS, #67691/95

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ON*SITE ALCOHOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology