FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK EKTACHEM DT SLIDES (URCR)
K Number: K934071
·
Decision Mar 21, 1994
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
238
Review Days
213
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Basic Information
- Device Name
- KODAK EKTACHEM DT SLIDES (URCR)
- K Number
- K934071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eastman Kodak Company
- Date Received
- August 20, 1993
- Decision Date
- March 21, 1994
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Eastman Kodak Company
| K Number | Device Name | ||
|---|---|---|---|
| K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 | Mar 31, 2006 | Substantially Equivalent |
| K060137 | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE | Mar 16, 2006 | Substantially Equivalent |
| K060079 | KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM | Feb 8, 2006 | Substantially Equivalent |
| K060055 | KODAK PACS | Feb 7, 2006 | Substantially Equivalent |
| K053347 | KODAK CARESTREAM PACS | Jan 4, 2006 | Substantially Equivalent |
| K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR | Jun 21, 2005 | Substantially Equivalent |
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 | Jun 1, 2005 | Substantially Equivalent |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | Sep 24, 2004 | Substantially Equivalent |
| K042158 | KODAK MEDICAL IMAGER 300 | Sep 24, 2004 | Substantially Equivalent |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | May 24, 2004 | Substantially Equivalent |