510(k) K061974 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Sep 15, 2006 |
| Received | Jul 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061974
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2011 | Instrumentation Laboratory Co. GEM PREMIER 4000 CARTRIDGE K+ REPORTING:
GEM 4000 BG/Hct/Lytes/CO-Ox
75 test iQM Part Number: 00027407508
150 test iQM Part Number: 00027415008
300 test iQM Part Number : 00027430008
450 tes Terminated |
CEM | None listed |
| Jul 21, 2011 | Instrumentation Laboratory Co. GEM PREMIER 4000 CARTRIDGE K+ REPORTING:
GEM 4000 BG/Hct/Lytes/CO-Ox/tBili
75 test iQM Part Number: 00027407509
150 test iQM Part Number: 00027415009
300 test iQM Part Number: 00027430009
450 t Terminated |
CEM | None listed |
| Jul 21, 2011 | Instrumentation Laboratory Co. GEM PREMIER 4000 CARTRIDGE K+ REPORTING:
GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili :
75 test iQM Part Number:00027407511
150 test iQM Part Number: 00027415011
300 test iQM Part Number: 00027430011
4 Terminated |
CEM | None listed |
| May 3, 2007 | Instrumentation Laboratory Co. GEM Premier 4000 Laboratory Analyzer Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.