Synermed Glucose Reagent Kit
FDA 510(k) K903063 · Synermed, Inc.
510(k) numberK903063
Submission
- Device name
- Synermed Glucose Reagent Kit
- Applicant
- Synermed, Inc.
Quebec, CA - Received
- July 9, 1990
- Decision date
- September 13, 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
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| 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 |
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| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K973109 | Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional | 09/25/1997SE |
| K972716 | Synermed Total Bilirubin Reagent KitCIG · Traditional | 08/07/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | 06/26/1997SE |
| K962479 | Synermed Ise ReagentsCGZ · Traditional | 03/03/1997SE |
| K963939 | Synermed Direct Bilirubin Reagent KitCIG · Traditional | 12/18/1996SE |
| K960793 | Synermed Enzymatic CO2 Reagent KitKHS · Traditional | 03/11/1996SE |
| K953395 | Synermed Calcium Reagent KitCJY · Traditional | 08/31/1995SE |
| K952179 | Synermed Ise ReagentsJGS · Traditional | 06/20/1995SE |
| K943924 | Creatinine-Po Reagent KitCGX · Traditional | 09/20/1994SE |
| K941091 | Synermed Amylase Reagent KitJFJ · Traditional | 05/03/1994SE |
Questions and answers
When was Synermed Glucose Reagent Kit cleared by the FDA?
Synermed Glucose Reagent Kit (K903063) received a 510(k) decision of Substantially Equivalent on September 13, 1990, 66 days after the submission was received.
What is the product code of K903063?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.