Medisense Pen 2/COMPANION 2 Blood Glucose System
FDA 510(k) K901613 · Medisense, Inc.
510(k) numberK901613
Submission
- Device name
- Medisense Pen 2/COMPANION 2 Blood Glucose System
- Applicant
- Medisense, Inc.
Cambridge, MA, US - Received
- April 6, 1990
- Decision date
- July 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252488 | ABL90 FLEX PLUS SystemCGA · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K210933 | YSI 2900C Biochemistry AnalyzerCGA · Traditional | Ysi, Inc. | 09/30/2024SE |
| K220328 | EasyStat 300CGA · Traditional | Medica Corporation | 07/26/2024SE |
| K223179 | Cholestech LDX SystemCGA · Dual Track | Alere San Diego, Inc. | 09/20/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 09/11/2023SE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 07/28/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 08/13/2021SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…CGA · Traditional | 07/09/1999SE |
| 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 |
Questions and answers
When was Medisense Pen 2/COMPANION 2 Blood Glucose System cleared by the FDA?
Medisense Pen 2/COMPANION 2 Blood Glucose System (K901613) received a 510(k) decision of Substantially Equivalent on July 10, 1990, 95 days after the submission was received.
What is the product code of K901613?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.