GEM Premier 3000— 510(k) K161818
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K161818 for GEM Premier 3000, Substantially Equivalent on 2016-09-14. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
Recent devices under product code CGA
view allMore clearances from Instrumentation Laboratory CO
view allAdverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161818
K-number listed on FDA's recall record- Z-0357-2024 — GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
- Z-0358-2024 — GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
- Z-0359-2024 — GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161818.
Data sourced from openFDA. This site is unofficial and independent of the FDA.