KODAK EKTACHEM 700 ANALYZER
FDA 510(k) clearance K833833 · decided 1984-01-17
Clearance details
- K-number
- K833833
- Device name
- KODAK EKTACHEM 700 ANALYZER
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1983-11-03
- Decision date
- 1984-01-17
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP recall (Z-0296-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |