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510(k) K964588

WATERS 515 HPLC PUMP (515) by Waters Corporation — Product Code KIE

K964588 is an FDA 510(k) premarket notification submitted by Waters Corporation for the device "WATERS 515 HPLC PUMP (515)". The FDA issued a decision of Substantially Equivalent on November 29, 1996. The device falls under product code KIE (Apparatus, 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
November 29, 1996
Date Received
November 15, 1996
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 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)
  • K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (July 22, 1996)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)

Other clearances for product code KIE

  • K935666 — PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (April 26, 1994)
  • K924347 — WATERS(TM) 996 PDA (December 11, 1992)
  • 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