Atlas FDA

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

FDA 510(k) clearance K093623 · decided 2010-06-18

Clearance details

K-number
K093623
Device name
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
Applicant
Instrumentation Laboratory CO
Decision
Substantially Equivalent
Date received
2009-11-23
Decision date
2010-06-18
Days to decision
207 days
Clearance type
Traditional
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Bedford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part Numb recall (Z-2803-2011)Instrumentation Laboratory Co.2011-07-21
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part recall (Z-2804-2011)Instrumentation Laboratory Co.2011-07-21
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM Par recall (Z-2805-2011)Instrumentation Laboratory Co.2011-07-21
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test i recall (Z-2806-2011)Instrumentation Laboratory Co.2011-07-21
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a porta recall (Z-2165-2011)Instrumentation Laboratory Co.2011-05-10