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510(k) K063868

MASSTRAK IMMUNOSUPPRESSANTS KIT by Waters Corporation — Product Code MLM

K063868 is an FDA 510(k) premarket notification submitted by Waters Corporation for the device "MASSTRAK IMMUNOSUPPRESSANTS KIT". The FDA issued a decision of Substantially Equivalent on May 25, 2007. The device falls under product code MLM (Enzyme Immunoassay, Tracrolimus), a Class II device regulated under 21 CFR 862.1678. Waters Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2007
Date Received
December 29, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Tracrolimus
Device Class
Class II
Regulation Number
862.1678
Review Panel
TX
Submission Type

Other clearances by Waters Corporation

  • K980180 — 2700 SAMPLE MANAGER (February 12, 1998)
  • K973074 — 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (October 6, 1997)
  • K964588 — WATERS 515 HPLC PUMP (515) (November 29, 1996)
  • K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (July 22, 1996)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)

Other clearances for product code MLM

  • K203833 — Tacrolimus Assay Kit (January 27, 2023)
  • K173857 — Elecsys Tacrolimus (November 6, 2018)
  • K150168 — Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibra (November 4, 2015)
  • K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (July 11, 2013)
  • K070820 — ARCHITECT TACROLIMUS: MODEL 1L77 (August 1, 2007)
  • K060502 — DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 (May 18, 2006)
  • K060385 — EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT (April 6, 2006)
  • K050206 — CEDIA TACROLIMUS ASSAY (March 15, 2005)

FDA data resources