GEM Premier 3000
FDA 510(k) clearance K161818 · decided 2016-09-14
Clearance details
- K-number
- K161818
- Device name
- GEM Premier 3000
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2016-07-01
- Decision date
- 2016-09-14
- Days to decision
- 75 days
- Clearance type
- Special
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- 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
| Record | Firm | Date |
|---|---|---|
| GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345 recall (Z-0357-2024) | Instrumentation Laboratory | 2023-11-21 |
| GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 000243 recall (Z-0358-2024) | Instrumentation Laboratory | 2023-11-21 |
| GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Number recall (Z-0359-2024) | Instrumentation Laboratory | 2023-11-21 |