Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (High, Normal, Low)
FDA 510(k) K110587 · Bayer Healthcare, LLC
510(k) numberK110587
Submission
- Device name
- Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (High, Normal, Low)
- Applicant
- Bayer Healthcare, LLC
Tarrytown, NY, US - Received
- March 1, 2011
- Decision date
- March 28, 2012
- 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
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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 |
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| K122370 | Contour Next Link Wireless Blood Glucose MonitorNBW · Traditional | 09/26/2013SE |
| K121190 | Contour Next Blood Glucose MeterLFR · Special | 07/26/2012SE |
| K121087 | Contour Next Usb Blood Glucose Monitoring SystemNBW · Special | 06/28/2012SE |
| K110894 | Contour Next Link Wireless Blood Glucose MeterLFR · Traditional | 03/28/2012SE |
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Questions and answers
When was Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (High, Normal, Low) cleared by the FDA?
Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (High, Normal, Low) (K110587) received a 510(k) decision of Substantially Equivalent on March 28, 2012, 393 days after the submission was received.
What is the product code of K110587?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.