Supercheck 1 Blood Glucose Monitoring System, Model 6268
FDA 510(k) K091815 · Biotest Medical Corp.
510(k) numberK091815
Submission
- Device name
- Supercheck 1 Blood Glucose Monitoring System, Model 6268
- Applicant
- Biotest Medical Corp.
Fairfax, VA, US - Received
- June 18, 2009
- Decision date
- November 16, 2009
- 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 |
|---|---|---|
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)NBW · Special | 09/20/2017SE |
| K171785 | WowGoHealth Blood Glucose Monitoring SystemNBW · Special | 09/15/2017SE |
| K141351 | Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose…NBW · Traditional | 05/19/2015SE |
| K133509 | Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring…NBW · Special | 02/21/2014SE |
| K123559 | Solusmobile Blood Glucose Managment SystemNBW · Traditional | 06/28/2013SE |
| K122525 | Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood…NBW · Special | 05/02/2013SE |
| K100560 | Easy Talk Blood Glucose Monitoring System Model: 6277NBW · Special | 05/12/2010SE |
| K100701 | Smartest Persona Blood Glucose Test Sytem Model: 6277NBW · Special | 04/08/2010SE |
| K093764 | SOLOV2 Blood Glucose Monitoring SystemNBW · Special | 03/02/2010SE |
Questions and answers
When was Supercheck 1 Blood Glucose Monitoring System, Model 6268 cleared by the FDA?
Supercheck 1 Blood Glucose Monitoring System, Model 6268 (K091815) received a 510(k) decision of Substantially Equivalent on November 16, 2009, 151 days after the submission was received.
What is the product code of K091815?
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.