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510(k) K790943

TRISEDTA-BORATE ELECTROPHORESIS FILM AGA by Corning Medical & Scientific — Product Code GHS

K790943 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "TRISEDTA-BORATE ELECTROPHORESIS FILM AGA". The FDA issued a decision of Substantially Equivalent on June 22, 1979. The device falls under product code GHS (Assay, Carboxyhemoglobin), a Class II device regulated under 21 CFR 864.7425. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1979
Date Received
May 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Carboxyhemoglobin
Device Class
Class II
Regulation Number
864.7425
Review Panel
HE
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 GHS

  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)
  • K910827 — ABL520 BLOOD GAS SYSTEM (July 9, 1991)
  • K771263 — RADIOMHTER OSM-2 HEMOXIMETER (August 3, 1977)
  • K770209 — ECOLYZER CARBOXIMETER (March 7, 1977)

FDA data resources