FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IL TEST THEOPHYLLINE
K Number: K943979
·
Decision Jan 18, 1995
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
321
Review Days
225
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Basic Information
- Device Name
- IL TEST THEOPHYLLINE
- K Number
- K943979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- June 7, 1994
- Decision Date
- January 18, 1995
- Product Code
- KLS
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.
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FDA Class 2
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MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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