Glucoleader Value
FDA 510(k) K023279 · Hmd Biomedical, Inc.
510(k) numberK023279
Submission
- Device name
- Glucoleader Value
- Applicant
- Hmd Biomedical, Inc.
Ocean, NJ, US - Received
- October 1, 2002
- Decision date
- August 4, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code NBW
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|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| 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
| 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 |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | 02/14/2013SE |
| 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 |
Questions and answers
When was Glucoleader Value cleared by the FDA?
Glucoleader Value (K023279) received a 510(k) decision of Substantially Equivalent on August 4, 2003, 307 days after the submission was received.
What is the product code of K023279?
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.