EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
FDA 510(k) clearance K954933 · decided 1995-12-18
Clearance details
- K-number
- K954933
- Device name
- EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-27
- Decision date
- 1995-12-18
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- 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 ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemi recall (Z-0292-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |