FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMINED STANDARD SOLUTION
K Number: K130100
·
Decision Apr 18, 2013
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
9
Review Days
93
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Basic Information
- Device Name
- COMINED STANDARD SOLUTION
- K Number
- K130100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mesa Laboratories, Inc.
- Date Received
- January 15, 2013
- Decision Date
- April 18, 2013
- Product Code
- FKH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKH | Solution-Test Standard-Conductivity, Dialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKH), ordered by most recent decision date.
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STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
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Other Clearances by Mesa Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201765 | SmartHDM-510 System | Sep 2, 2020 | Substantially Equivalent |
| K191496 | TDS Standard Solution | Aug 5, 2019 | Substantially Equivalent |
| K150657 | Phoenix XL Dialysate Meter | Sep 21, 2015 | Substantially Equivalent |
| K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR | Dec 3, 2014 | Substantially Equivalent |
| K122362 | SMART-WELL INCUBATOR | Mar 26, 2013 | Substantially Equivalent |
| K112018 | SMART READ EZTEST STEAM | Jan 30, 2012 | Substantially Equivalent |
| K050812 | 90XL INSTRUMENTATION SYSTEM | May 5, 2005 | Substantially Equivalent |
| K033330 | CONDUCTIVITY/TDS CALIBRATOR SOLUTION | Feb 27, 2004 | Substantially Equivalent |