ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG— 510(k) K831271
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K831271 for ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG, Substantially Equivalent on 1983-07-26. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Recent devices under product code GKZ
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Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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.