FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HI-M-TEST MORPHINE
K Number: K791551
·
Decision Oct 17, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
3
Review Days
64
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Basic Information
- Device Name
- HI-M-TEST MORPHINE
- K Number
- K791551
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Technam, Inc.
- Date Received
- August 14, 1979
- Decision Date
- October 17, 1979
- Product Code
- DLR
- 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 |
|---|---|---|---|
| DLR | Hemagglutination Inhibition, Morphine | FDA class 2 | Clinical Toxicology |
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