Home / 510(k) Clearances / K850359

510(k) K850359

WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D by Millipore Corp. — Product Code LDM

K850359 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code LDM (Instrumentation, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
January 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrumentation, High Pressure Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type

Other clearances by Millipore Corp.

  • K023892 — MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (January 17, 2003)
  • K013988 — MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (April 4, 2002)
  • K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (June 10, 1997)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)
  • K924347 — WATERS(TM) 996 PDA (December 11, 1992)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K914841 — CHROMATOGRAPHY CLINICAL USE 75JQR (December 10, 1991)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)

Other clearances for product code LDM

  • K960392 — CDM (July 8, 1996)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)
  • K942451 — BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (November 10, 1994)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)
  • K884886 — MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (February 2, 1989)
  • K872582 — HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (July 16, 1987)
  • K870949 — WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (April 22, 1987)
  • K862178 — ISOPURE LC SYSTEM (July 14, 1986)

FDA data resources