VITROS CHEMISTRY PRODUCTS CRBM SLIDES
FDA 510(k) clearance K980283 · decided 1998-02-25
Clearance details
- K-number
- K980283
- Device name
- VITROS CHEMISTRY PRODUCTS CRBM SLIDES
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-26
- Decision date
- 1998-02-25
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- KLT
- Device class
- 2
- Regulation number
- 862.3645
- 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 CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, In recall (Z-1470-2014) | Ortho-Clinical Diagnostics | 2014-04-17 |
| VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382 recall (Z-0307-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
| Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diag recall (Z-1016-05) | Ortho-Clinical Diagnostics | 2005-07-16 |