Atlas FDA

STA R MAX

FDA 510(k) clearance K151867 · decided 2015-08-07

Clearance details

K-number
K151867
Device name
STA R MAX
Applicant
Diagnostica Stago S.A.S
Decision
Substantially Equivalent
Date received
2015-07-09
Decision date
2015-08-07
Days to decision
29 days
Clearance type
Special
Product code
JPA
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Gennevilliers, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, recall (Z-1575-2023)Diagnostica Stago, Inc.2023-05-10