The following data is part of a premarket notification filed by Sakura Finetek U.s.a., Inc. with the FDA for Sakura Drs-60 Automatic Slide Stainer.
Device ID | K874897 |
510k Number | K874897 |
Device Name: | SAKURA DRS-60 AUTOMATIC SLIDE STAINER |
Classification | Slide Stainer, Automated |
Applicant | SAKURA FINETEK U.S.A., INC. 23440 HAWTHORNE BLVD. SUITE 240 Torrance, CA 90505 |
Contact | Robert A Clark |
Correspondent | Robert A Clark SAKURA FINETEK U.S.A., INC. 23440 HAWTHORNE BLVD. SUITE 240 Torrance, CA 90505 |
Product Code | KPA |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-01 |
Decision Date | 1988-01-05 |