FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDX QUINIDINE
K Number: K822653
·
Decision Sep 28, 1982
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
26
Applicant Total
883
Review Days
26
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Basic Information
- Device Name
- TDX QUINIDINE
- K Number
- K822653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- September 2, 1982
- Decision Date
- September 28, 1982
- Product Code
- LBZ
- 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 |
|---|---|---|---|
| LBZ | Enzyme Immunoassay, Quinidine | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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