FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDX THEOPHYLLINE
K Number: K833070
·
Decision Nov 14, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
883
Review Days
67
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Basic Information
- Device Name
- TDX THEOPHYLLINE
- K Number
- K833070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- September 8, 1983
- Decision Date
- November 14, 1983
- Product Code
- LER
- 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 |
|---|---|---|---|
| LER | Fluorescent Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
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