510(k) K952816 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
LIPASE FLEX REAGENT CARTRIDGE
| Applicant | Dupont Medical Products, Wilmington DE, US |
| Decision | Substantially Equivalent, Jul 20, 1995 |
| Received | Jun 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Lipase Flex Reagent Cartridge, Model Number 10460277
Product Usage:
Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and Terminated |
CHI | None listed |
| Sep 7, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745
Product Usage:
Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in huma Terminated |
CHI | None listed |
| Dec 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension LIP Flex Reagent Cartridge, Catalog# DF55A Terminated |
CHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.