FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRUG ABUSE DIPSTICKS
K Number: K790805
·
Decision Jun 6, 1979
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
3
Review Days
42
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Basic Information
- Device Name
- DRUG ABUSE DIPSTICKS
- K Number
- K790805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Technical Resources, Inc.
- Date Received
- April 25, 1979
- Decision Date
- June 6, 1979
- Product Code
- DIT
- 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 |
|---|---|---|---|
| DIT | Thin Layer Chromatography, Amphetamine | FDA class 2 | Clinical Toxicology |
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