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510(k) K811257

CORNING 965 CARBON DIOXIDE ANALYZER by Corning Medical & Scientific — Product Code CHS

K811257 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "CORNING 965 CARBON DIOXIDE ANALYZER". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code CHS (Coulometric Method, 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
May 27, 1981
Date Received
May 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coulometric Method, 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 CHS

  • K926320 — REFLAB SYSTEM PACK LIQUID CO2 REAGENT (February 3, 1993)
  • K911838 — ROCHE REAGENT FOR C02 (July 19, 1991)
  • K860660 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (March 14, 1986)
  • K841080 — TECHNICON RA-1000 SYS CO2 (May 2, 1984)
  • K802376 — KODAK EKTA-CHEM CLINICAL CHEM. SLIDES (October 23, 1980)

FDA data resources