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510(k) K861146

MODEL K110SX CENTRIFUGE by Jouan S.A. — Product Code JQC

K861146 is an FDA 510(k) premarket notification submitted by Jouan S.A. for the device "MODEL K110SX CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on May 5, 1986. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1986
Date Received
March 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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FDA data resources