Home / 510(k) Clearances / K872916

510(k) K872916

HISTOMATIC SLIDE STAINER, CODE-ON VERSION by Fisher Scientific Co., LLC — Product Code KPA

K872916 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "HISTOMATIC SLIDE STAINER, CODE-ON VERSION". The FDA issued a decision of Substantially Equivalent on September 14, 1987. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1987
Date Received
July 24, 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 Fisher Scientific Co., LLC

  • K930415 — MICROHEMATOCRIT ROTOR (March 23, 1993)
  • K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (March 11, 1992)
  • K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (January 8, 1992)
  • K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (March 8, 1989)
  • K881275 — URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II (May 16, 1988)
  • K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (October 20, 1987)
  • K871058 — SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) (April 6, 1987)
  • K863224 — HEMATALL-C PLUS HEMATOLOGY CONTROLS (October 29, 1986)
  • K862318 — FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR (July 10, 1986)
  • K861185 — THERACHEM-PLUS, TRI-LEVEL TDC (TM) (May 23, 1986)

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)
  • K874897 — SAKURA DRS-60 AUTOMATIC SLIDE STAINER (January 5, 1988)
  • K853210 — MST-1050-II X-RAY UNIT (October 10, 1985)
  • K850333 — PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (February 27, 1985)
  • K850157 — CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS (February 27, 1985)
  • K842077 — MIDAS II AUTOMATIC STAINER (July 27, 1984)

FDA data resources