FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AT HOME DRUG TEST, MODEL 9073 T
K Number: K010650
·
Decision Mar 30, 2001
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
47
Review Days
25
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
- AT HOME DRUG TEST, MODEL 9073 T
- K Number
- K010650
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech
- Date Received
- March 5, 2001
- Decision Date
- March 30, 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 Phamatech
| K Number | Device Name | ||
|---|---|---|---|
| K041578 | QUICKSCREEN, MODELS 9177X AND 9178X | Sep 10, 2004 | Substantially Equivalent |
| K030447 | AT HOME DRUG CUP, MODEL 9150X | Apr 14, 2003 | Substantially Equivalent |
| K010833 | AT WORK DRUG TEST, MODEL 9177T AWT | Apr 11, 2001 | Substantially Equivalent |
| K010836 | AT WORK DRUG TEST, MODEL 9147T AWT | Apr 11, 2001 | Substantially Equivalent |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | Apr 5, 2001 | Substantially Equivalent |
| K010653 | AT HOME DRUG TEST, MODEL 9068 T | Apr 5, 2001 | Substantially Equivalent |
| K010655 | AT HOME DRUG TESTT, MODEL 9150 T | Apr 5, 2001 | Substantially Equivalent |
| K010645 | AT HOME DRUG TEST, MODEL 9063 T | Mar 30, 2001 | Substantially Equivalent |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | Mar 30, 2001 | Substantially Equivalent |
| K010651 | AT HOME DRUG TEST, MODEL 9133 T | Mar 30, 2001 | Substantially Equivalent |