GEM-CRIT CHECK
FDA 510(k) clearance K871686 · decided 1987-06-18
Clearance details
- K-number
- K871686
- Device name
- GEM-CRIT CHECK
- Applicant
- Diamond Sensor Systems
- Decision
- Substantially Equivalent
- Date received
- 1987-04-29
- Decision date
- 1987-06-18
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.