FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTAREAD LITHIUM SYSTEM
K Number: K031579
·
Decision Dec 19, 2003
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
11
Applicant Total
3
Review Days
213
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Basic Information
- Device Name
- INSTAREAD LITHIUM SYSTEM
- K Number
- K031579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3560
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Akers Laboratories, Inc.
- Date Received
- May 20, 2003
- Decision Date
- December 19, 2003
- Product Code
- JIH
- 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 |
|---|---|---|---|
| JIH | Flame Photometry, Lithium | FDA class 2 | Clinical Toxicology |
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