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510(k) K780031

FLUORESCENCE DETECTOR MODEL 420 by Waters Assoc., Inc. — Product Code KHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1978
Date Received
January 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

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  • K801431 — PAN-AM MYELOGRAM TRAY (August 12, 1980)
  • K791661 — SYSTEM CONTROLLER 720 SERIES (September 24, 1979)
  • K791026 — 4F STERILE BALLOON-LESS, CATHETER 913-28 (June 22, 1979)
  • K782175 — CARTRIDGE HOLDER, RCM 100 (February 15, 1979)
  • K790145 — SOLVENT DELIVERY SYSTEM (February 15, 1979)
  • K781805 — CARDIAC COMPUTERS, CO-10 & CO-10R (January 29, 1979)
  • K781915 — DATA MODULE (January 10, 1979)

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