510(k) K040919 ยท HRX Arthroscope
NUCLEOTOME PROBE SET, MODEL 21200
| Applicant | Clarus Medical, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 1, 2004 |
| Received | Apr 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EC8+ 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.