FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISION THEOPHYLLINE II
K Number: K896927
·
Decision Jan 18, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
883
Review Days
37
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Basic Information
- Device Name
- VISION THEOPHYLLINE II
- K Number
- K896927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- December 12, 1989
- Decision Date
- January 18, 1990
- 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 510(k)
FDA Class 2
·Clinical Toxicology
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