FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALCOHOL REAGENT SET
K Number: K972725
·
Decision Sep 25, 1997
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
74
Review Days
66
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Basic Information
- Device Name
- ALCOHOL REAGENT SET
- K Number
- K972725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pointe Scientific, Inc.,
- Date Received
- July 21, 1997
- Decision Date
- September 25, 1997
- Product Code
- DIC
- 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 |
|---|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | FDA class 2 | Clinical Toxicology |
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