FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
K Number: K042080
·
Decision Aug 19, 2004
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
22
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
- K Number
- K042080
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Home Diagnostics, Inc.
- Date Received
- August 3, 2004
- Decision Date
- August 19, 2004
- Product Code
- JJX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJX), ordered by most recent decision date.
Beta-CrossLaps CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elecsys CYFRA 21-1 CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Multichem A1c
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Audit MicroControls Linearity DROP LQ Blood Glucose
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON CMV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON EBV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Home Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090495 | TRUEBALANCE BLOOD GLUCOSE SYSTEM | Mar 27, 2009 | Substantially Equivalent |
| K080641 | TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 | Aug 19, 2008 | Substantially Equivalent |
| K080710 | TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 | Aug 13, 2008 | Substantially Equivalent |
| K070593 | TRACKRECORD DATA MANAGEMENT SOFTWARE | May 7, 2007 | Substantially Equivalent |
| K060793 | ELEMENT BLOOD GLUCOSE TEST SYSTEM | Jul 25, 2006 | Substantially Equivalent |
| K051147 | SIDEKICK BLOOD GLUCOSE TEST SYSTEM | Jul 12, 2005 | Substantially Equivalent |
| K040670 | MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL | Mar 25, 2004 | Substantially Equivalent |
| K032657 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) | Mar 24, 2004 | Substantially Equivalent |
| K030703 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS | Jul 11, 2003 | Substantially Equivalent |
| K010403 | PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 | Mar 26, 2001 | Substantially Equivalent |