VITROS SPECIALTY DILUENT
FDA 510(k) clearance K962235 · decided 1996-06-26
Clearance details
- K-number
- K962235
- Device name
- VITROS SPECIALTY DILUENT
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-11
- Decision date
- 1996-06-26
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinica recall (Z-1519-2014) | Ortho-Clinical Diagnostics | 2014-04-28 |
| VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD recall (Z-1520-2014) | Ortho-Clinical Diagnostics | 2014-04-28 |