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510(k) K962574

WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) by Waters Corporation — Product Code LEQ

K962574 is an FDA 510(k) premarket notification submitted by Waters Corporation for the device "WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)". The FDA issued a decision of Substantially Equivalent on July 22, 1996. The device falls under product code LEQ (Detectors, Electrochemical, 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 22, 1996
Date Received
July 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detectors, Electrochemical, 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)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)

Other clearances for product code LEQ

  • K903231 — COULOCHEM II (September 27, 1990)
  • K864729 — NEUROCHEMICAL ANALYZER (April 13, 1987)
  • K801439 — MODEL 5100 ELECTROCHEMICAL DETECTOR (July 21, 1980)

FDA data resources