FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COCAINE DIPSTICK TEST, MODEL D747-A
K Number: K010239
·
Decision Jun 25, 2001
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
51
Review Days
151
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
- COCAINE DIPSTICK TEST, MODEL D747-A
- K Number
- K010239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- January 25, 2001
- Decision Date
- June 25, 2001
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIO), ordered by most recent decision date.
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Emit II Plus Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Teco Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K170118 | Scanostics UTI Check Application Test System | Sep 21, 2017 | Substantially Equivalent |
| 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 |