510(k) K161818 ยท CGA Glucose Oxidase, Glucose
GEM Premier 3000
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Sep 14, 2016 |
| Received | Jul 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 Open, Classified |
CHL | None listed |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007 Open, Classified |
CHL | None listed |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009 Open, Classified |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.