DeviceClearance

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER— 510(k) K093167

Substantially Equivalent

Diagnostica 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
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
Download summary PDFView on FDA.gov ↗

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Adverse 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 record

Matched 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.