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510(k) K802037

VITAMIN B12 FOLATE RADIOASSAY by Corning Medical & Scientific — Product Code CCN

K802037 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "VITAMIN B12 FOLATE RADIOASSAY". The FDA issued a decision of Substantially Equivalent on November 21, 1980. The device falls under product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge), a Class I device regulated under 21 CFR 868.2300. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1980
Date Received
August 22, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Device Class
Class I
Regulation Number
868.2300
Review Panel
AN
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 CCN

  • K934945 — FLOWMETER NIPPLE ADAPTOR (November 17, 1993)
  • K920783 — OXYGEN FLOW CONTROLLER (September 18, 1992)
  • K872038 — NEB-U-VENT (August 10, 1987)
  • K871262 — MODIFIED NOFLO I (July 21, 1987)
  • K863613 — NO-FLO I (December 15, 1986)
  • K863659 — FLOW INTERRUPTION INDICATOR (October 15, 1986)
  • K863657 — OXYGEN CONSERVATOR (October 15, 1986)
  • K823775 — BORDON GAGE REGULATOR #BG (January 14, 1983)

FDA data resources