Chemcard Glucose Test
FDA 510(k) K943503 · Chem-Elec, Inc.
510(k) numberK943503
Submission
- Device name
- Chemcard Glucose Test
- Applicant
- Chem-Elec, Inc.
North Webster, IN, US - Received
- July 20, 1994
- Decision date
- July 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K811165 | Glucose Oxidase Rate ReagentCGA · Traditional | 08/13/1981SE |
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Questions and answers
When was Chemcard Glucose Test cleared by the FDA?
Chemcard Glucose Test (K943503) received a 510(k) decision of Substantially Equivalent on July 23, 1996, 734 days after the submission was received.
What is the product code of K943503?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.