GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.— 510(k) K882450
Substantially EquivalentDiamond Sensor Systems
FDA 510(k) clearance K882450 for GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK., Substantially Equivalent on 1988-07-28. Applicant: Diamond Sensor Systems. Device class: 1.
Clearance details
- Applicant
- Diamond Sensor Systems
- Product code
- Code JJE
- Device class
- Class 1
- Regulation
- 21 CFR 862.2160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
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- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K130276 — DIMENSION EXL WITH LM SYSTEM
More clearances from Diamond Sensor Systems
view allAdverse events under product code JJE
product code JJE- Death
- 6
- Injury
- 441
- Malfunction
- 25,011
- Other
- 1
- Total
- 25,459
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.