One Touch Ultrasmart Blood Glucose Monitoring System
FDA 510(k) K021819 · Lifescan, Inc.
510(k) numberK021819
Submission
- Device name
- One Touch Ultrasmart Blood Glucose Monitoring System
- Applicant
- Lifescan, Inc.
Milpitas, CA, US - Received
- June 4, 2002
- Decision date
- August 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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 |
|---|---|---|
| K132618 | Onetouch RevealMRZ · Traditional | 12/16/2013SE |
| K120558 | Onetouch Reveal Diabetes Management ApplicationNBW · Traditional | 02/07/2013SE |
| K093745 | One Touch Verio Blood Glucose Monitoring SystemNBW · Traditional | 02/11/2011SE |
| K082590 | Symphony Meter RemoteLZG · Traditional | 12/17/2008SE |
| K082513 | Onetouch Vita Blood Glucose Monitoring SystemNBW · Special | 10/22/2008SE |
| K081318 | Onetouch Zoom Diabetes Management ProgramNBW · Special | 06/09/2008SE |
| K073231 | Onetouch Ultralink Blood Glucose Monitoring SystemNBW · Traditional | 04/18/2008SE |
| K072543 | Onetouch Select Blood Glucose Monitoring SystemNBW · Special | 10/05/2007SE |
| K062195 | Modification to One Touch Ultra Blood Glucose Monitoring SystemNBW · Special | 08/16/2006SE |
| K061118 | Onetouch Ultramini Blood Glucose Monitoring SystemNBW · Special | 05/19/2006SE |
Questions and answers
When was One Touch Ultrasmart Blood Glucose Monitoring System cleared by the FDA?
One Touch Ultrasmart Blood Glucose Monitoring System (K021819) received a 510(k) decision of Substantially Equivalent on August 23, 2002, 80 days after the submission was received.
What is the product code of K021819?
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.