GEM Premier 5000
FDA 510(k) clearance K203790 · decided 2021-08-20
Clearance details
- K-number
- K203790
- Device name
- GEM Premier 5000
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2020-12-28
- Decision date
- 2021-08-20
- Days to decision
- 235 days
- Clearance type
- Special
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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