Hemocue B-Glucose System
FDA 510(k) K961311 · Hemocue, Inc.
510(k) numberK961311
Submission
- Device name
- Hemocue B-Glucose System
- Applicant
- Hemocue, Inc.
Potomac, MD, US - Received
- April 4, 1996
- Decision date
- August 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | Hmd Biomedical, Inc. | 02/14/2013SE |
| 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 |
More from Taidoc Technology Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | 08/04/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | 02/01/2019SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | 10/25/2007SE |
| K060765 | Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL…LFR · Traditional | 09/06/2006SE |
| K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801GKR · Traditional | 06/08/2006SE |
| K053253 | Hemocue Albumin 201 Analyzing SystemKQO · Traditional | 02/17/2006SE |
| K041234 | Hemocue Hemoglobin 201DM Analyzing SystemGKR · Special | 06/10/2004SE |
| K041230 | Clinical Laboratory Analyzing SystemLFR · Special | 05/20/2004SE |
| K032203 | Hemocue Hemoglobin 201 + System Article 121704GKR · Special | 08/25/2003SE |
| K020935 | Hemocue Glucose 201 System, Article Number 120706CGA · Special | 04/03/2002SE |
Questions and answers
When was Hemocue B-Glucose System cleared by the FDA?
Hemocue B-Glucose System (K961311) received a 510(k) decision of Substantially Equivalent on August 23, 1996, 141 days after the submission was received.
What is the product code of K961311?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.