FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK EKTACHEM CLINICAL CHEM. SLIDES
K Number: K800628
·
Decision Apr 10, 1980
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
160
Applicant Total
238
Review Days
21
Basic Information
- Device Name
- KODAK EKTACHEM CLINICAL CHEM. SLIDES
- K Number
- K800628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- EASTMAN KODAK COMPANY
- Date Received
- March 20, 1980
- Decision Date
- April 10, 1980
- 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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|---|---|---|---|
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| K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR | Jun 21, 2005 | Substantially Equivalent |
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 | Jun 1, 2005 | Substantially Equivalent |
| K042158 | KODAK MEDICAL IMAGER 300 | Sep 24, 2004 | Substantially Equivalent |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | Sep 24, 2004 | Substantially Equivalent |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | May 24, 2004 | Substantially Equivalent |