STA R Max 3, STA Compact Max 3
K-Number: K212183 · 2023-06-07
ApplicantDiagnostica Stago S.A.S
Decision Date2023-06-07
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
STA R Max 3, STA Compact Max 3 is a medical device manufactured by Diagnostica Stago S.A.S. It received FDA 510(k) clearance on 2023-06-07 under approval number K212183. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STA R Max 3, STA Compact Max 3?
STA R Max 3, STA Compact Max 3 is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by Diagnostica Stago S.A.S. The 510(k) number is K212183.
When was STA R Max 3, STA Compact Max 3 approved by the FDA?
STA R Max 3, STA Compact Max 3 received FDA 510(k) clearance on 2023-06-07, under approval number K212183.
What company makes STA R Max 3, STA Compact Max 3?
STA R Max 3, STA Compact Max 3 is manufactured by Diagnostica Stago S.A.S.
What is the FDA product code for STA R Max 3, STA Compact Max 3?
The FDA product code for STA R Max 3, STA Compact Max 3 is JPA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.