510(k) K040918 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, May 17, 2004 |
| Received | Apr 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT CG8+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.