FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K Number: K813349
·
Decision Dec 22, 1981
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
47
Review Days
25
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Basic Information
- Device Name
- BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
- K Number
- K813349
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- November 27, 1981
- Decision Date
- December 22, 1981
- Product Code
- DIF
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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