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510(k) K772112

NON-FERMENTER SYSTEM by Corning Medical & Scientific — Product Code JSW

K772112 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "NON-FERMENTER SYSTEM". The FDA issued a decision of Substantially Equivalent on November 17, 1977. The device falls under product code JSW (Kit, Identification, Glucose Nonfermenter), 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
November 17, 1977
Date Received
November 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Glucose Nonfermenter
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)
  • 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 JSW

  • K922768 — RAPID NFT, MODIFICATION (October 14, 1992)
  • K900517 — RAPID NF SYSTEM (March 13, 1990)
  • K870769 — AUSTIN NONFERMENTER KIT (April 3, 1987)
  • K790992 — PSEUDO-PALETTE TM (June 22, 1979)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)

FDA data resources