KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
FDA 510(k) clearance K941142 · decided 1994-06-13
Clearance details
- K-number
- K941142
- Device name
- KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1994-03-10
- Decision date
- 1994-06-13
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- DIP
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique recall (Z-0202-2016) | Ortho-Clinical Diagnostics | 2015-11-02 |
| VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in recall (Z-0007-2015) | Ortho-Clinical Diagnostics | 2014-10-02 |
| VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VI recall (Z-0321-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |