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510(k) K811697

GUAMSTAINER by Tomtec — Product Code KPA

K811697 is an FDA 510(k) premarket notification submitted by Tomtec for the device "GUAMSTAINER". The FDA issued a decision of Substantially Equivalent on July 2, 1981. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. Tomtec has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1981
Date Received
June 16, 1981
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 Tomtec

  • K771569 — AUTOSTREAKER (October 25, 1977)

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)
  • 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)

FDA data resources