FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K Number: K993165
·
Decision Oct 20, 1999
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
47
Review Days
28
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
- QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
- K Number
- K993165
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech
- Date Received
- September 22, 1999
- Decision Date
- October 20, 1999
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DJG), ordered by most recent decision date.
Labcorp Fentanyl Urine Visual Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Evidence MultiSTAT DOA Urine MultiPlex
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LZI Buprenorphine II Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SEFRIA Hydrocodone Oral Fluid
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LZI Fentanyl III Enzyme Immunoassay
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 |