GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
FDA 510(k) K150274 · Infopia Co, Ltd.
510(k) numberK150274
Submission
- Device name
- GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
- Applicant
- Infopia Co, Ltd.
Anyang, KR - Received
- February 4, 2015
- Decision date
- August 26, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
More from Ascensia Diabetes Care
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|---|---|---|
| K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose…NBW · Special | 09/28/2016SE |
| K141750 | Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemLCP · Special | 07/24/2014SE |
| K132406 | Elementv Blood Glucose Monitoring SystemNBW · Traditional | 04/18/2014SE |
| K133045 | Element TM Lite Blood Glucose Monitoring SystemNBW · Traditional | 04/10/2014SE |
| K132862 | Healthpro Professional Blood Glucose Monitoring SystemNBW · Special | 12/12/2013SE |
| K132966 | Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…NBW · Traditional | 12/05/2013SE |
| K130181 | Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring SystemNBW · Traditional | 07/31/2013SE |
| K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…NBW · Special | 06/21/2013SE |
| K121366 | Hemocue HBA1C 501LCP · Special | 09/07/2012SE |
| K113192 | Healthpro Blood Glucose Monitoring SystemNBW · Traditional | 07/13/2012SE |
Questions and answers
When was GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System cleared by the FDA?
GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System (K150274) received a 510(k) decision of Substantially Equivalent on August 26, 2015, 203 days after the submission was received.
What is the product code of K150274?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.