GEM PREMIER 3000
FDA 510(k) clearance K052121 · decided 2005-10-21
Clearance details
- K-number
- K052121
- Device name
- GEM PREMIER 3000
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2005-08-05
- Decision date
- 2005-10-21
- Days to decision
- 77 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 |
|---|---|---|
| Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Prem recall (Z-2673-2011) | Instrumentation Laboratory Co. | 2011-06-27 |
| GEM PREMIER 3000 recall (Z-0378-06) | Instrumentation Laboratory Co. | 2006-01-11 |