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510(k) K874897

SAKURA DRS-60 AUTOMATIC SLIDE STAINER by Sakura Finetek U.S.A., Inc. — Product Code KPA

K874897 is an FDA 510(k) premarket notification submitted by Sakura Finetek U.S.A., Inc. for the device "SAKURA DRS-60 AUTOMATIC SLIDE STAINER". The FDA issued a decision of Substantially Equivalent on January 5, 1988. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. Sakura Finetek U.S.A., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1988
Date Received
December 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Slide Stainer, Automated
Device Class
Class I
Regulation Number
864.3800
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)
  • K881165 — SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (July 1, 1988)

Other clearances for product code KPA

  • K933996 — PROFIBLOT (January 28, 1994)
  • K884258 — VERSABLOT (December 14, 1988)
  • K881592 — WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (May 13, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)
  • K874887 — WESBLOT PROCESSOR (March 24, 1988)
  • K872916 — HISTOMATIC SLIDE STAINER, CODE-ON VERSION (September 14, 1987)
  • K853210 — MST-1050-II X-RAY UNIT (October 10, 1985)
  • K850157 — CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS (February 27, 1985)
  • K850333 — PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (February 27, 1985)
  • K842077 — MIDAS II AUTOMATIC STAINER (July 27, 1984)

FDA data resources