Home Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices: 22

Catalogue22

Newest first, rows 1-22 of 22

Rows 1-22 of 22

Frequently asked questions

How many devices does Home Diagnostics, Inc. have in the registry?

The registry currently lists 22 devices for Home Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Home Diagnostics, Inc.'s devices?

Among its 22 most recently registered devices, Home Diagnostics, Inc. has devices listed in FDA 510(k) (22 devices).

What risk classes do Home Diagnostics, Inc.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for Home Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Home Diagnostics, Inc. in the registry?

The most recently registered devices listed for Home Diagnostics, Inc. include DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP, TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81, TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 and PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.

Home Diagnostics, Inc.

Catalogue22

Diascan Blood Glucose Monitoring Test Strip Ref K915772

Trueresult Blood Glucose System E4H01-81 Ref K080641 Open recall

TRUE2GO Blood Glucose System, Model F4H01-81 Ref K080710 Open recall

Prestige Lx Blood Glucose Test System Ref K992988

Modification To Truetrack Smart System Blood Glucose Meter, Test Strips And Glucose Control Ref K040670

Truebalance Blood Glucose System Ref K090495 Open recall

Prestige Blood Glucose Monitoring System, Meter, Test Strips & Prestige High And Low Glucose Control Ref K960855

Truetrack Smart System Blood Glucose Meter And True Track Smart System Blood Glucose Test Strips Ref K030703 Open recall

Ultra+ Blood Glucose Monitoring Test Strip Ref K922136

Element Blood Glucose Test System Ref K060793

Ultra Blood Glucose Monitoring System Ref K912440

Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700 Ref K010403

Trackrecord Data Management Software Ref K070593

Diascan* Blood Glucose Self-Monitoring Test Strips Ref K872505

Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, And Glucose Control Solutions (Low And High) Ref K032657 Open recall

Diascan Control Ref K853553

Trackease Smart System Blood Glucose System Ref K042080 Open recall

Diascan Blood Glucose Monitoring Test Strip Ref K922137

Ultra+ Blood Glucose Test Strip Ref K915770

Diascan Blood Glucose Self-Monitor Test Strips Ref K851618

Sidekick Blood Glucose Test System Ref K051147

Dialet Lancing Device Ref K861265

Frequently asked questions