FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ON-SITE ALCOHOL
K Number: K903223
·
Decision Mar 13, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
5
Review Days
233
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Basic Information
- Device Name
- ON-SITE ALCOHOL
- K Number
- K903223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Toxi-Lab, Inc.
- Date Received
- July 23, 1990
- Decision Date
- March 13, 1991
- Product Code
- DOJ
- 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 |
|---|---|---|---|
| DOJ | Potassium Dichromate, Alcohol | FDA class 2 | Clinical Toxicology |
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