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510(k) K770792

TUBE, STAIN, RETICULOCYTE, LARC by Corning Medical & Scientific — Product Code KFC

K770792 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "TUBE, STAIN, RETICULOCYTE, LARC". The FDA issued a decision of Substantially Equivalent on July 5, 1977. The device falls under product code KFC (Methylene Blue, Tissue Stain), a Class I device regulated under 21 CFR 864.1850. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1977
Date Received
May 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methylene Blue, Tissue Stain
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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 KFC

  • K875310 — RETICULOCYTE STAIN (February 9, 1988)
  • K843919 — SPOTTEST LOEFFLER METHYLENE BLUE STAIN (October 30, 1984)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 1984)
  • K842926 — METHYLENE BLUE STAIN, LOEFFLER (September 11, 1984)
  • K842743 — NEW METHYLENE BLUE N (August 12, 1984)
  • K831502 — NEPHROLYTE (July 18, 1983)

FDA data resources