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510(k) K963268

GENESIS RMP by Tecan U.S., Inc. — Product Code JRA

K963268 is an FDA 510(k) premarket notification submitted by Tecan U.S., Inc. for the device "GENESIS RMP". The FDA issued a decision of Substantially Equivalent on March 18, 1997. The device falls under product code JRA (Microtitrator, For Clinical Use), a Class I device regulated under 21 CFR 862.2680. Tecan U.S., Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1997
Date Received
August 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtitrator, For Clinical Use
Device Class
Class I
Regulation Number
862.2680
Review Panel
CH
Submission Type

Other clearances by Tecan U.S., Inc.

  • K953345 — GENESIS (November 21, 1995)
  • 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)

FDA data resources