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510(k) K872273

CORNING EASY WASH ELISA PLATES by Corning Medical & Scientific — Product Code LIB

K872273 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "CORNING EASY WASH ELISA PLATES". The FDA issued a decision of Substantially Equivalent on July 7, 1987. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1987
Date Received
June 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Corning Medical & Scientific

  • K875122 — DISPOSABLE STERILE SYRINGE FILTERS (January 12, 1988)
  • 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)
  • K844671 — CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (February 25, 1985)

Other clearances for product code LIB

  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)
  • K920416 — SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (April 8, 1992)
  • K912558 — GULL ELISAWARE (September 16, 1991)
  • K871559 — CELL LIFTER (May 15, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)

FDA data resources