FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
K Number: K902356
·
Decision Jul 16, 1990
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
28
Applicant Total
238
Review Days
48
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Basic Information
- Device Name
- KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
- K Number
- K902356
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3830
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Eastman Kodak Company
- Date Received
- May 29, 1990
- Decision Date
- July 16, 1990
- Product Code
- DKJ
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DKJ | Colorimetry, Salicylate | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKJ), ordered by most recent decision date.
ADVIA CHEMISTRY SALICYLATE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SALICYLATE-SL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |