FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE STEP MORPHINE CARD TEST
K Number: K970579
·
Decision Jul 3, 1997
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
3
Applicant Total
51
Review Days
139
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Basic Information
- Device Name
- ONE STEP MORPHINE CARD TEST
- K Number
- K970579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- February 14, 1997
- Decision Date
- July 3, 1997
- 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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