FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K Number: K872190
·
Decision Jun 24, 1987
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
160
Applicant Total
89
Review Days
16
Basic Information
- Device Name
- NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
- K Number
- K872190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- NOVA BIOMEDICAL CORP.
- Date Received
- June 8, 1987
- Decision Date
- June 24, 1987
- 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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