FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
K Number: K911060
·
Decision May 8, 1991
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
1
Review Days
58
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Basic Information
- Device Name
- IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
- K Number
- K911060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Immunomatrix
- Date Received
- March 11, 1991
- Decision Date
- May 8, 1991
- 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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