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510(k) K881165

SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR by Sakura Finetek U.S.A., Inc. — Product Code IEO

K881165 is an FDA 510(k) premarket notification submitted by Sakura Finetek U.S.A., Inc. for the device "SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code IEO (Processor, Tissue, Automated), a Class I device regulated under 21 CFR 864.3875. Sakura Finetek U.S.A., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1988
Date Received
March 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Tissue, Automated
Device Class
Class I
Regulation Number
864.3875
Review Panel
PA
Submission Type

Other clearances by Sakura Finetek U.S.A., Inc.

  • K893811 — SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM (September 7, 1989)
  • K882881 — SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER (July 28, 1988)
  • K874897 — SAKURA DRS-60 AUTOMATIC SLIDE STAINER (January 5, 1988)

Other clearances for product code IEO

  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K853938 — LX 300 TISSUE PROCESSOR (October 10, 1985)
  • K851054 — LX120 TISSUE PROCESSOR (May 15, 1985)
  • K843506 — LKB 2189 ULTROPROCESSOR (November 30, 1984)
  • K834599 — AUTOTECHNICON V TISSUE PROCESS SYS (February 4, 1984)
  • K831313 — TISSUE-TEK V.I.P. 100/200 (July 28, 1983)
  • K801427 — TISSUE-TEK III MINI-RAPID PROCESSOR (July 28, 1980)
  • K801513 — TISSUE PROCESSING SYSTEM (July 28, 1980)
  • K771308 — TISSUE-TEK III V.I.P. (August 22, 1977)

FDA data resources