FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERDICT BARBITURATES
K Number: K963529
·
Decision Oct 30, 1996
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
99
Applicant Total
7
Review Days
56
Basic Information
- Device Name
- VERDICT BARBITURATES
- K Number
- K963529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EDITEK, INC.
- Date Received
- September 4, 1996
- Decision Date
- October 30, 1996
- Product Code
- DIS
- 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 |
|---|---|---|---|
| DIS | Enzyme Immunoassay, Barbiturate | 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 |
| K963516 | VERDICT THC | Oct 30, 1996 | Substantially Equivalent |
| K943710 | VERDICT COCAINE | Nov 17, 1994 | Substantially Equivalent |
| K943712 | VERDICT OPIATES | Nov 17, 1994 | Substantially Equivalent |
| K943711 | EZ-SCREEN:PCP | Sep 9, 1994 | Substantially Equivalent |