Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems
FDA 510(k) K121433 · Hmd Biomedical, Inc.
510(k) numberK121433
Submission
- Device name
- Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems
- Applicant
- Hmd Biomedical, Inc.
Xinpu Township, Hsinchu County, TW - Received
- May 14, 2012
- Decision date
- February 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LFR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR · Special | Abott Laboratories | 09/17/2015SE |
| K142089 | Accu-Chek Aviva Expert SystemLFR · Traditional | Roche Diagnostics Corporation | 12/17/2014SE |
| K133537 | EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemLFR · Special | Eps Bio Technology Corp. | 04/28/2014SE |
| K131727 | Cera-Chek 1070 Blood Glucose Monitoring SystemLFR · Traditional | Ceragem Medisys, Inc. | 02/28/2014SE |
| K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemLFR · Traditional | Roche Diagnostics Operations, Inc. | 10/11/2013SE |
| K122688 | Nova Max Mini Blood Glucose and B-Ketone MonitorLFR · Traditional | Nova Biomedical Corporation | 04/04/2013SE |
| K122435 | Nova One Blood Glucose MonitorLFR · Traditional | Nova Biomedical Corporation | 12/20/2012SE |
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemLFR · Traditional | Hmd Biomedical, Inc. | 11/09/2012SE |
| K121224 | Genesis Health Technologies Blood Glucose Monitoring SystemLFR · Special | Taidoc Technology Corporation | 09/19/2012SE |
| K113307 | GL Goodlife Series Blood Glucose Monitoring SysmtemLFR · Traditional | Hmd Biomedical, Inc. | 07/27/2012SE |
More from Hmd Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring SystemNBW · Special | 08/29/2022SE |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring SystemNBW · Traditional | 05/08/2019SE |
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose…NBW · Special | 05/14/2015SE |
| K131173 | FIA Blood Glucose Monitoring System (G2)NBW · Traditional | 09/18/2014SE |
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemLFR · Traditional | 11/09/2012SE |
| K120064 | Test, Blood Glucose SystemNBW · Traditional | 09/05/2012SE |
| K113307 | GL Goodlife Series Blood Glucose Monitoring SysmtemLFR · Traditional | 07/27/2012SE |
| K072369 | Evolution Blood Glucose Monitoring SystemNBW · Traditional | 03/21/2008SE |
| K032985 | Glucoleader Enhance Self-Monitoring of Blood Glucose SystemNBW · Special | 10/21/2003SE |
| K023279 | Glucoleader ValueNBW · Traditional | 08/04/2003SE |
Questions and answers
When was Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems cleared by the FDA?
Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems (K121433) received a 510(k) decision of Substantially Equivalent on February 14, 2013, 276 days after the submission was received.
What is the product code of K121433?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.