510(k) K052121 ยท CGA Glucose Oxidase, Glucose
GEM PREMIER 3000
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Oct 21, 2005 |
| Received | Aug 5, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052121
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2011 | Instrumentation Laboratory Co. Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer
PN 00026000000
The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whol Terminated |
CHL | None listed |
| Jan 11, 2006 | Instrumentation Laboratory Co. GEM PREMIER 3000 Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.