Satellite C Blood Cholesterol Monitoring System
FDA 510(k) K896467 · Medisense, Inc.
510(k) numberK896467
Submission
- Device name
- Satellite C Blood Cholesterol Monitoring System
- Applicant
- Medisense, Inc.
Cambridge, MA, US - Received
- November 13, 1989
- Decision date
- June 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
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| 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 Satellite C Blood Cholesterol Monitoring System cleared by the FDA?
Satellite C Blood Cholesterol Monitoring System (K896467) received a 510(k) decision of Substantially Equivalent on June 12, 1990, 211 days after the submission was received.
What is the product code of K896467?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.