Atlas FDA

STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER

FDA 510(k) clearance K082248 · decided 2008-12-12

Clearance details

K-number
K082248
Device name
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
Applicant
Diagnostica Stago, Inc.
Decision
Substantially Equivalent
Date received
2008-08-08
Decision date
2008-12-12
Days to decision
126 days
Clearance type
Traditional
Product code
JPA
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Parisppany, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a recall (Z-2473-2025)Diagnostica Stago, Inc.2025-08-28
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical recall (Z-0252-2013)Diagnostica Stago, Inc.2012-11-06