510(k) K893811

SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM by Sakura Finetek U.S.A., Inc. — Product Code JQW

K893811 is an FDA 510(k) premarket notification submitted by Sakura Finetek U.S.A., Inc. for the device "SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 7, 1989. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Sakura Finetek U.S.A., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1989
Date Received
May 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type