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510(k) K801599

CORNING 184 BLOOD GAS TONOMETER by Corning Medical & Scientific — Product Code LCH

K801599 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "CORNING 184 BLOOD GAS TONOMETER". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code LCH (Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical), a Class I device regulated under 21 CFR 862.1660. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Device Class
Class I
Regulation Number
862.1660
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 LCH

  • K922386 — RNA MEDICAL TONOMETER (June 26, 1992)
  • K904163 — CLINICAL BLOOD GAS MIXTURES (November 1, 1990)
  • K900819 — BLOOD GAS CALIBRATION STANDARD (April 25, 1990)
  • K862958 — AMR RESEARCH TONOMETER (November 24, 1986)
  • K841089 — LINEAR CLOUD TONOMETER (May 22, 1984)
  • K802379 — HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER (October 31, 1980)
  • K781417 — PRECISION GAS MIXER (September 20, 1978)
  • K781386 — EBS 775 TONOMETER (September 14, 1978)

FDA data resources