The following data is part of a premarket notification filed by Sakura Finetek U.s.a., Inc. with the FDA for Sakura Prep Ai Automatic Liquid Handling System.
Device ID | K893811 |
510k Number | K893811 |
Device Name: | SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | SAKURA FINETEK U.S.A., INC. 22828 LOCKNESS AVE. Torrance, CA 90501 |
Contact | Robert A Clark |
Correspondent | Robert A Clark SAKURA FINETEK U.S.A., INC. 22828 LOCKNESS AVE. Torrance, CA 90501 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-22 |
Decision Date | 1989-09-07 |