FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Scanostics UTI Check Application Test System
K Number: K170118
·
Decision Sep 21, 2017
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
12
Applicant Total
51
Review Days
251
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Basic Information
- Device Name
- Scanostics UTI Check Application Test System
- K Number
- K170118
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1510
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teco Diagnostics
- Date Received
- January 13, 2017
- Decision Date
- September 21, 2017
- Product Code
- JMT
- 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 |
|---|---|---|---|
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Teco Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Jul 24, 2015 | Substantially Equivalent |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | May 29, 2014 | Substantially Equivalent |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | Oct 4, 2011 | Substantially Equivalent |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | Feb 17, 2011 | Substantially Equivalent |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | Feb 4, 2011 | Substantially Equivalent |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | May 8, 2008 | Substantially Equivalent |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Apr 18, 2008 | Substantially Equivalent |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Apr 11, 2007 | Substantially Equivalent |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Jan 26, 2007 | Substantially Equivalent |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | Jul 14, 2006 | Substantially Equivalent |