FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHANOL
K Number: K013538
·
Decision Dec 14, 2001
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
883
Review Days
51
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Basic Information
- Device Name
- ETHANOL
- K Number
- K013538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- October 24, 2001
- Decision Date
- December 14, 2001
- Product Code
- DML
- 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 |
|---|---|---|---|
| DML | Nad-Nadh, Specific Reagent For Alcohol Enzyme Method | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DML), ordered by most recent decision date.
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SIGMA PROCEDURE NO. 333-UV
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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