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510(k) K933996

PROFIBLOT by Tecan U.S., Ltd. — Product Code KPA

K933996 is an FDA 510(k) premarket notification submitted by Tecan U.S., Ltd. for the device "PROFIBLOT". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. Tecan U.S., Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
August 17, 1993
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 Tecan U.S., Ltd.

  • K963268 — GENESIS RMP (March 18, 1997)
  • K953345 — GENESIS (November 21, 1995)
  • K944556 — 4 CHANNEL DISPENSER (October 25, 1994)
  • K942655 — 4 CHANNEL DISPENSER (September 2, 1994)
  • K915492 — RSP MEGA SAMPLE PROCESSOR (February 21, 1992)
  • K912036 — ROBOTIC SAMPLE PROCESSOR (July 26, 1991)
  • K910740 — SLT MICROPLATE WASHER (March 27, 1991)
  • K894126 — ROBOTIC SAMPLE PROCESSOR (August 15, 1989)
  • K854406 — TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 (February 10, 1986)

Other clearances for product code KPA

  • 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)
  • 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