FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIALET LANCING DEVICE
K Number: K861265
·
Decision Apr 30, 1986
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
22
Review Days
26
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Basic Information
- Device Name
- DIALET LANCING DEVICE
- K Number
- K861265
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Home Diagnostics, Inc.
- Date Received
- April 4, 1986
- Decision Date
- April 30, 1986
- Product Code
- FMK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Heel Incision Safety Lancet (SteriHeel 2)
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Other Clearances by Home Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K042080 | TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM | Aug 19, 2004 | 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 |