FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHLYTE ELECTROLYTE ANALYZER
K Number: K905600
·
Decision Jan 15, 1991
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
161
Applicant Total
3
Review Days
32
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Basic Information
- Device Name
- TECHLYTE ELECTROLYTE ANALYZER
- K Number
- K905600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technalysis, Inc.
- Date Received
- December 14, 1990
- Decision Date
- January 15, 1991
- 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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