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510(k) K771610

CARBON DIOXIDE ANALYZER by Corning Medical & Scientific — Product Code CIE

K771610 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "CARBON DIOXIDE ANALYZER". The FDA issued a decision of Substantially Equivalent on October 7, 1977. The device falls under product code CIE (Volumetric/Manometric, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1977
Date Received
August 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Volumetric/Manometric, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
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 CIE

  • K904761 — P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT (November 20, 1990)
  • K880967 — MICRO CO2 APPARATUS (April 28, 1988)
  • K864313 — CO2 REAGENT SET (March 13, 1987)
  • K832071 — TOTAL CO2 REAGENT SET (August 11, 1983)
  • K820091 — AIRMED SMOKE EVACUATION & FILTER (February 24, 1982)
  • K800524 — SERALYZER REFLECTANCE PHOTOMETER/CALIB. (April 2, 1980)

FDA data resources