GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
FDA 510(k) clearance K882450 · decided 1988-07-28
Clearance details
- K-number
- K882450
- Device name
- GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
- Applicant
- Diamond Sensor Systems
- Decision
- Substantially Equivalent
- Date received
- 1988-06-14
- Decision date
- 1988-07-28
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.