510(k) K093623 ยท CIG Diazo Colorimetry, Bilirubin
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jun 18, 2010 |
| Received | Nov 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093623
| 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/G/L/CO-Ox
75 test iQM Part Number : 00027407510
150 test iQM Part Number:00027415010
300 test iQM Part Number: 00027430010
450 test 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 10, 2011 | Instrumentation Laboratory Co. Instrumentation Laboratory GEM Premier 4000
PN 00025000000
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the p Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.