FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCEDURE #430 & REAGENTS FOR ACETAMIN
K Number: K822313
·
Decision Aug 24, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
231
Review Days
21
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Basic Information
- Device Name
- PROCEDURE #430 & REAGENTS FOR ACETAMIN
- K Number
- K822313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- August 3, 1982
- Decision Date
- August 24, 1982
- Product Code
- LDP
- 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 |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
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