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510(k) K953345

GENESIS by Tecan U.S., Inc. — Product Code JQW

K953345 is an FDA 510(k) premarket notification submitted by Tecan U.S., Inc. for the device "GENESIS". The FDA issued a decision of Substantially Equivalent on November 21, 1995. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Tecan U.S., Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1995
Date Received
July 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type

Other clearances by Tecan U.S., Inc.

  • K963268 — GENESIS RMP (March 18, 1997)
  • K944556 — 4 CHANNEL DISPENSER (October 25, 1994)
  • K942655 — 4 CHANNEL DISPENSER (September 2, 1994)
  • K933996 — PROFIBLOT (January 28, 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 JQW

  • K023955 — BD VIPER INSTRUMENT (June 24, 2003)
  • K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (April 30, 1998)
  • K980180 — 2700 SAMPLE MANAGER (February 12, 1998)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K970616 — MINI SAMPLER PROCESSOR (April 21, 1997)
  • K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (March 28, 1997)
  • K962859 — MINI SAMPLE PROCESSOR (October 29, 1996)
  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K961694 — IMPACT (June 21, 1996)
  • K951753 — MEDTEC AUTOBLOT 2000 (October 17, 1995)

FDA data resources