Sakura HEM-480 Electron Microscopy Processor

FDA 510(k) K881165 · Sakura Finetek U.S.A., Inc.

Substantially Equivalent

510(k) numberK881165

Submission

Device name
Sakura HEM-480 Electron Microscopy Processor
Applicant
Sakura Finetek U.S.A., Inc.
Torrance, CA, US
Received
March 20, 1988
Decision date
July 1, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IEO – Processor, Tissue, Automated
Device class
Class I (low risk)
Regulation
21 CFR 864.3875
Specialty
Pathology

Other 510(k)s with product code IEO

510(k)DeviceApplicantDecision
K924590Microwave Automated Tissue ProcessorIEO · Traditional Innovative Medical Systems, Inc.12/29/1992SE
K883599LX-80 Automated Tissue Processor (Plastic)IEO · Traditional Innovative Medical Systems, Inc.09/02/1988SE
K853938LX 300 Tissue ProcessorIEO · Traditional Innovative Medical Systems, Inc.10/10/1985SE
K851054LX120 Tissue ProcessorIEO · Traditional Innovative Medical Systems, Inc.05/15/1985SE
K843506LKB 2189 UltroprocessorIEO · Traditional Lkb Instruments, Inc.11/30/1984SE
K834599Autotechnicon V Tissue Process SysIEO · Traditional Technicon Instruments Corp.02/04/1984SE
K831313Tissue-Tek V.I.P. 100/200IEO · Traditional Miles Laboratories, Inc.07/28/1983SE
K801513Tissue Processing SystemIEO · Traditional Innovative Medical Systems, Inc.07/28/1980SE
K801427Tissue-Tek III Mini-Rapid ProcessorIEO · Traditional Miles Laboratories, Inc.07/28/1980SE
K771308Tissue-Tek III V.I.P.IEO · Traditional Miles Laboratories, Inc.08/22/1977SE

More from Miles Laboratories, Inc.

510(k)DeviceDecision
K893811Sakura Prep Ai Automatic Liquid Handling SystemJQW · Traditional 09/07/1989SE
K882881Sakura-Medscand SCA-1800 Automatic CoverslipperKES · Traditional 07/28/1988SE
K874897Sakura DRS-60 Automatic Slide StainerKPA · Traditional 01/05/1988SE

Questions and answers

When was Sakura HEM-480 Electron Microscopy Processor cleared by the FDA?

Sakura HEM-480 Electron Microscopy Processor (K881165) received a 510(k) decision of Substantially Equivalent on July 1, 1988, 103 days after the submission was received.

What is the product code of K881165?

The FDA product code is IEO – Processor, Tissue, Automated, a Class I (low risk) device regulated under 21 CFR 864.3875.