FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERDICT COCAINE
K Number: K943710
·
Decision Nov 17, 1994
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
144
Applicant Total
7
Review Days
108
Basic Information
- Device Name
- VERDICT COCAINE
- K Number
- K943710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EDITEK, INC.
- Date Received
- August 1, 1994
- Decision Date
- November 17, 1994
- Product Code
- DIO
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
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Other Clearances by EDITEK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K963692 | VERDICT PCP | Dec 10, 1996 | Substantially Equivalent |
| K963233 | EZ-SCREEN PROFILE | Oct 31, 1996 | Substantially Equivalent |
| K963529 | VERDICT BARBITURATES | Oct 30, 1996 | Substantially Equivalent |
| K963516 | VERDICT THC | Oct 30, 1996 | Substantially Equivalent |
| K943712 | VERDICT OPIATES | Nov 17, 1994 | Substantially Equivalent |
| K943711 | EZ-SCREEN:PCP | Sep 9, 1994 | Substantially Equivalent |