FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUINIDINE FLUORESCENT IMMUNOASSAY
K Number: K832493
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
26
Applicant Total
39
Review Days
47
Basic Information
- Device Name
- QUINIDINE FLUORESCENT IMMUNOASSAY
- K Number
- K832493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN DIAGNOSTIC CORP.
- Date Received
- July 27, 1983
- Decision Date
- September 12, 1983
- Product Code
- LBZ
- 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 |
|---|---|---|---|
| LBZ | Enzyme Immunoassay, Quinidine | FDA class 2 | Clinical Toxicology |
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