FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ON*SITE ALCOHOL
K Number: K923337
·
Decision Jan 12, 1993
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
5
Review Days
208
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Basic Information
- Device Name
- ON*SITE ALCOHOL
- K Number
- K923337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Toxi-Lab, Inc.
- Date Received
- June 18, 1992
- Decision Date
- January 12, 1993
- 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 |
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