Atlas FDA

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

FDA 510(k) clearance K093167 · decided 2009-12-22

Clearance details

K-number
K093167
Device name
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
Applicant
Diagnostica Stago, Inc.
Decision
Substantially Equivalent
Date received
2009-10-07
Decision date
2009-12-22
Days to decision
76 days
Clearance type
Special
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 Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 recall (Z-1576-2023)Diagnostica Stago, Inc.2023-05-10