Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood Glucose Monitoring System
FDA 510(k) K022182 · Abbott Laboratories
510(k) numberK022182
Submission
- Device name
- Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood Glucose Monitoring System
- Applicant
- Abbott Laboratories
Bedford, MA, US - Received
- July 3, 2002
- Decision date
- September 9, 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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| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
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| 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 |
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Questions and answers
When was Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood Glucose Monitoring System cleared by the FDA?
Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood Glucose Monitoring System (K022182) received a 510(k) decision of Substantially Equivalent on September 9, 2002, 68 days after the submission was received.
What is the product code of K022182?
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.