510(k) K897150 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
| Applicant | Toyo Jozo Co., Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Feb 26, 1990 |
| Received | Dec 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897150
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-B
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01. Terminated |
CHI | None listed |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-C
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | None listed |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-D
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | None listed |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-E
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.