Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST
FDA 510(k) K983504 · Medisense, Inc.
510(k) numberK983504
Submission
- Device name
- Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST
- Applicant
- Medisense, Inc.
Bedford, MA, US - Received
- October 6, 1998
- Decision date
- July 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
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More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager System…CGA · Traditional | 12/08/1998SE |
| K983253 | Precision A1C Home HBA1C Sample Collection KitLCP · Traditional | 11/20/1998SE |
| K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripCGA · Traditional | 08/08/1997SE |
| K963676 | Precision G Blood Glucose Testing SystemCGA · Traditional | 02/20/1997SE |
| K962295 | Precision Qid Blood Glucose Test StripCGA · Traditional | 07/26/1996SE |
| K961337 | Exactech RSG Blood Glucose Testing SystemCGA · Traditional | 06/21/1996SE |
| K952279 | Precision Link Blood Glucose Data Management SystemCGA · Traditional | 06/14/1995SE |
| K945887 | Precision Q I D Blood Glucose Test StripsCGA · Traditional | 03/23/1995SE |
| K944195 | Quickpro Blood Glucose Testing SystemCGA · Traditional | 03/23/1995SE |
| K901613 | Medisense Pen 2/COMPANION 2 Blood Glucose SystemCGA · Traditional | 07/10/1990SE |
Questions and answers
When was Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST cleared by the FDA?
Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST (K983504) received a 510(k) decision of Substantially Equivalent on July 9, 1999, 276 days after the submission was received.
What is the product code of K983504?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.