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510(k) K910740

SLT MICROPLATE WASHER by Tecan U.S., Ltd. — Product Code JJQ

K910740 is an FDA 510(k) premarket notification submitted by Tecan U.S., Ltd. for the device "SLT MICROPLATE WASHER". The FDA issued a decision of Substantially Equivalent on March 27, 1991. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Tecan U.S., Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1991
Date Received
February 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
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)
  • K933996 — PROFIBLOT (January 28, 1994)
  • K915492 — RSP MEGA SAMPLE PROCESSOR (February 21, 1992)
  • K912036 — ROBOTIC SAMPLE PROCESSOR (July 26, 1991)
  • K894126 — ROBOTIC SAMPLE PROCESSOR (August 15, 1989)
  • K854406 — TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 (February 10, 1986)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (February 4, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)

FDA data resources