FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
K Number: K111206
·
Decision Oct 4, 2011
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
51
Review Days
158
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Basic Information
- Device Name
- TECO DIAGNOSTICS SALIVA ALCOHOL TEST
- K Number
- K111206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teco Diagnostics
- Date Received
- April 29, 2011
- Decision Date
- October 4, 2011
- Product Code
- DIC
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | May 29, 2014 | 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 |