FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME
K Number: K821154
·
Decision May 13, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
1
Review Days
17
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Basic Information
- Device Name
- KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME
- K Number
- K821154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Jay Rau, Technical Suppprt
- Date Received
- April 26, 1982
- Decision Date
- May 13, 1982
- Product Code
- KLS
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
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