STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER— 510(k) K093167
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K093167 for STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER, Substantially Equivalent on 2009-12-22. Applicant: Diagnostica Stago, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- Product code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Parisppany, NJ, US
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More clearances from Diagnostica Stago, Inc.
view allAdverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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 →
Recalls naming K093167
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093167.
Data sourced from openFDA. This site is unofficial and independent of the FDA.