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510(k) K924347

WATERS(TM) 996 PDA by Millipore Corp. — Product Code KIE

K924347 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "WATERS(TM) 996 PDA". The FDA issued a decision of Substantially Equivalent on December 11, 1992. The device falls under product code KIE (Apparatus, 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
December 11, 1992
Date Received
August 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, 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)
  • 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)
  • K872792 — WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM (July 31, 1987)

Other clearances for product code KIE

  • K964588 — WATERS 515 HPLC PUMP (515) (November 29, 1996)
  • K935666 — PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (April 26, 1994)
  • K914841 — CHROMATOGRAPHY CLINICAL USE 75JQR (December 10, 1991)
  • K911299 — EQUIPMENT/MATERIAL DECONTAMINATING KIT (April 8, 1991)
  • K862506 — THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR (July 29, 1986)
  • K844947 — EMIT ANCILLARY REAGENTS (June 28, 1985)
  • K844949 — SYVA SAMPLE SEAL (February 15, 1985)
  • K800556 — DIFFERENTIAL REFRACTIVE INDEX DETECTOR (March 25, 1980)
  • K800516 — DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. (March 19, 1980)
  • K800289 — LDC SPECTROMONITOR III (February 26, 1980)

FDA data resources