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510(k) K770662

VIEWER, FLUOROMETIC, MODEL 721 by Corning Medical & Scientific — Product Code JZT

K770662 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "VIEWER, FLUOROMETIC, MODEL 721". The FDA issued a decision of Substantially Equivalent on April 15, 1977. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
April 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer
Device Class
Class I
Regulation Number
866.4520
Review Panel
IM
Submission Type

Other clearances by Corning Medical & Scientific

  • K875122 — DISPOSABLE STERILE SYRINGE FILTERS (January 12, 1988)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K872076 — CORNING DISPOSABLE ROLLER BOTTLES (June 15, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K854024 — CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (November 26, 1985)
  • K853634 — CORNING CELL WELLS-MULTIPLE WELL PLATES (September 16, 1985)
  • K851939 — CORNING CERTAIN -ISE (June 14, 1985)
  • K851329 — MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA (June 13, 1985)
  • K850806 — CORNING BLOOD COLLECTION CAPILLARY TUBES (March 25, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)

Other clearances for product code JZT

  • K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (September 5, 1996)
  • K883349 — QLIA IMMUNOCHEMISTRY SYSTEM (September 7, 1988)
  • K882677 — STAT-20 FLUOROMETER (July 12, 1988)
  • K864699 — FLUORESCENCE CONCENTRATION ANALYZER (FCA) (December 22, 1986)
  • K863434 — THE FIAX 5000 FLUOROMETER (October 29, 1986)
  • K862674 — PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM (August 15, 1986)
  • K852240 — SMS, SCREEN MACHINE SYSTEM (June 11, 1985)
  • K842049 — FLUOROSKAN (December 3, 1984)
  • K843356 — FIAX 100 FLUOROMETER (September 17, 1984)
  • K834070 — IMMPULSE SYSTEM (March 23, 1984)

FDA data resources