ClearanceBrief
510(k) K992834 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

GEM PREMIER 3000

ApplicantInstrumentation Laboratory CO, Lexington MA, US
DecisionSubstantially Equivalent, Nov 24, 1999
ReceivedAug 23, 1999
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K992834

DateFirm and productCodeLinked 510(k)
Nov 21, 2023Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Open, Classified		 CHLNone listed
Nov 21, 2023Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Open, Classified		 CHLNone listed
Nov 21, 2023Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Open, Classified		 CHLNone listed
May 20, 2003Instrumentation Laboratory Co.
GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Terminated		 CHLNone listed
May 20, 2003Instrumentation Laboratory Co.
GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
Terminated		 CHLNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.