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510(k) K961557

ALLIANCE 2690 SEPARATIONS MODULE by Waters Corporation — Product Code LDM

K961557 is an FDA 510(k) premarket notification submitted by Waters Corporation for the device "ALLIANCE 2690 SEPARATIONS MODULE". The FDA issued a decision of Substantially Equivalent on July 5, 1996. The device falls under product code LDM (Instrumentation, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Waters Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1996
Date Received
April 22, 1996
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 Waters Corporation

  • K063868 — MASSTRAK IMMUNOSUPPRESSANTS KIT (May 25, 2007)
  • 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)

Other clearances for product code LDM

  • K960392 — CDM (July 8, 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)
  • K850272 — WATERS 740 DATA MODULE-PLOTTER INTEGRATOR (March 6, 1985)

FDA data resources