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510(k) K811975

MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL by Waters Assoc., Inc. — Product Code JJQ

K811975 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL". The FDA issued a decision of Substantially Equivalent on July 27, 1981. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1981
Date Received
July 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

Other clearances by Waters Assoc., Inc.

  • K802481 — 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH (October 31, 1980)
  • K801852 — MRM-2 OXYGEN CONSUMPTION MONITOR (August 20, 1980)
  • 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)
  • K790145 — SOLVENT DELIVERY SYSTEM (February 15, 1979)
  • K782175 — CARTRIDGE HOLDER, RCM 100 (February 15, 1979)
  • K781805 — CARDIAC COMPUTERS, CO-10 & CO-10R (January 29, 1979)
  • K781915 — DATA MODULE (January 10, 1979)
  • K781692 — CALIBRATOR, DYNAMIC (November 29, 1978)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (February 4, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)

FDA data resources