FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDI QUIK TEST NARCOTICS DRUG SCREEN
K Number: K853140
·
Decision Mar 3, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
3
Applicant Total
4
Review Days
217
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Basic Information
- Device Name
- MDI QUIK TEST NARCOTICS DRUG SCREEN
- K Number
- K853140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Medical Diagnostics, Ca.
- Date Received
- July 29, 1985
- Decision Date
- March 3, 1986
- Product Code
- DNK
- 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 |
|---|---|---|---|
| DNK | Thin Layer Chromatography, Morphine | FDA class 2 | Clinical Toxicology |
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