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510(k) K850333

PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS by Shaban Mfg. Co. — Product Code KPA

K850333 is an FDA 510(k) premarket notification submitted by Shaban Mfg. Co. for the device "PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS". The FDA issued a decision of Substantially Equivalent on February 27, 1985. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. Shaban Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1985
Date Received
January 28, 1985
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 Shaban Mfg. Co.

  • K853621 — REPLACEMENT PUMP TUBING (December 5, 1985)
  • K850157 — CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS (February 27, 1985)
  • K844781 — MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB (February 1, 1985)
  • K844235 — CHLORIDE STANDARD (November 20, 1984)
  • K842656 — REPLACEMENT PARTS NOVA ELECTROLYTE ANAL (August 12, 1984)
  • K841610 — COMPONENTS FOR POTASSIUM, SODIUM CHLO (May 25, 1984)
  • K841609 — COMPONENTS FOR PARTIAL PRESSURE ELEE (May 25, 1984)
  • K840557 — REAGENTS & STANDARDS IL 501 NA/K (April 4, 1984)
  • K840468 — PARTIAL PRESS. ELECTRODE MEASUREMENT (March 30, 1984)
  • K840530 — SUPPLIES FOR INSTRUMENTATION LAB FLAME (March 30, 1984)

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)
  • 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)
  • K842077 — MIDAS II AUTOMATIC STAINER (July 27, 1984)

FDA data resources