FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3
K Number: K892004
·
Decision Apr 21, 1989
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
319
Review Days
24
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Basic Information
- Device Name
- LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3
- K Number
- K892004
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- March 28, 1989
- Decision Date
- April 21, 1989
- Product Code
- LAS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | FDA class 1 | Clinical Toxicology |
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