510(k) K130332 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 31, 2013 |
| Received | Feb 11, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130332
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Terminated |
CDT | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930
VITROS TRIG Slides quantitatively measure triglyceride (T Terminated |
KLS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.