510(k) K001885 ยท CDN Urease, Photometric, Urea Nitrogen
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jul 20, 2000 |
| Received | Jun 21, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001885
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. Open, Classified |
CDN | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204
VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) o Terminated |
CDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.