Glucose Pilot
FDA 510(k) K052208 · Tianjin New Bay Bioresearch Co., Ltd.
510(k) numberK052208
Submission
- Device name
- Glucose Pilot
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
Carlsbad, CA, US - Received
- August 12, 2005
- Decision date
- December 9, 2005
- 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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| 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 |
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Questions and answers
When was Glucose Pilot cleared by the FDA?
Glucose Pilot (K052208) received a 510(k) decision of Substantially Equivalent on December 9, 2005, 119 days after the submission was received.
What is the product code of K052208?
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.