FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KODAK EKTACHEM 700 ANALYZER
K Number: K833833
·
Decision Jan 17, 1984
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
207
Applicant Total
238
Review Days
75
Basic Information
- Device Name
- KODAK EKTACHEM 700 ANALYZER
- K Number
- K833833
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- EASTMAN KODAK COMPANY
- Date Received
- November 3, 1983
- Decision Date
- January 17, 1984
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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