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510(k) K780650

FLAME PHOTOMETER, MODEL 455 by Corning Medical & Scientific — Product Code JJO

K780650 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "FLAME PHOTOMETER, MODEL 455". The FDA issued a decision of Substantially Equivalent on May 26, 1978. The device falls under product code JJO (Flame Emission Photometer For Clinical Use), a Class I device regulated under 21 CFR 862.2540. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1978
Date Received
April 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Emission Photometer For Clinical Use
Device Class
Class I
Regulation Number
862.2540
Review Panel
CH
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 JJO

  • K873603 — FINNIGAN MAT INCOS 50 (September 22, 1987)
  • K862148 — OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (September 29, 1986)
  • K843375 — ELVI 655 FLAME PHOTOMETER (May 20, 1985)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K834226 — FLAME PHOTOMETERS (June 22, 1984)
  • K841422 — VOLUME TEST DYE 6 (May 11, 1984)
  • K841421 — DAILY WASH SOLUTION 5 (May 11, 1984)
  • K840530 — SUPPLIES FOR INSTRUMENTATION LAB FLAME (March 30, 1984)
  • K840044 — SDI PREPAX DILUKIT 29-1000 (March 9, 1984)
  • K833535 — POTASSIUM SODIUM ANALYSIS PRODUCTS (December 29, 1983)

FDA data resources