Trackease Smart System Blood Glucose System
FDA 510(k) K042080 · Home Diagnostics, Inc.
510(k) numberK042080
Submission
- Device name
- Trackease Smart System Blood Glucose System
- Applicant
- Home Diagnostics, Inc.
Fort Lauderdale, FL, US - Received
- August 3, 2004
- Decision date
- August 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Trackease Smart System Blood Glucose System cleared by the FDA?
Trackease Smart System Blood Glucose System (K042080) received a 510(k) decision of Substantially Equivalent on August 19, 2004, 16 days after the submission was received.
What is the product code of K042080?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.