Diascan Blood Glucose Self-Monitor Test Strips
FDA 510(k) K851618 · Home Diagnostics, Inc.
510(k) numberK851618
Submission
- Device name
- Diascan Blood Glucose Self-Monitor Test Strips
- Applicant
- Home Diagnostics, Inc.
Eatontown, NJ, US - Received
- April 18, 1985
- Decision date
- August 6, 1985
- 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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| K042080 | Trackease Smart System Blood Glucose SystemJJX · Special | 08/19/2004SE |
| K040670 | Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose…NBW · Special | 03/25/2004SE |
| K032657 | Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose…NBW · Traditional | 03/24/2004SE |
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Questions and answers
When was Diascan Blood Glucose Self-Monitor Test Strips cleared by the FDA?
Diascan Blood Glucose Self-Monitor Test Strips (K851618) received a 510(k) decision of Substantially Equivalent on August 6, 1985, 110 days after the submission was received.
What is the product code of K851618?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.