FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K Number: K100673
·
Decision Apr 6, 2010
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
161
Applicant Total
47
Review Days
28
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Basic Information
- Device Name
- EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
- K Number
- K100673
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medica Corp.
- Date Received
- March 9, 2010
- Decision Date
- April 6, 2010
- Product Code
- JGS
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | FDA class 2 | Clinical Chemistry |
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