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510(k) K771303

FLAME PHOTOMETER MODEL 460 by Corning Medical & Scientific — Product Code JIH

K771303 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "FLAME PHOTOMETER MODEL 460". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code JIH (Flame Photometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1977
Date Received
July 15, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
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 JIH

  • K050338 — MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (March 4, 2005)
  • K031579 — INSTAREAD LITHIUM SYSTEM (December 19, 2003)
  • K011033 — DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (June 7, 2001)
  • K934106 — KODAK EKTACHEM DTSC II SLIDES (LI) (April 25, 1994)
  • K924488 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) (January 26, 1993)
  • K921403 — MODEL 654 ANALYZER (July 30, 1992)
  • K895465 — AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE (December 27, 1989)
  • K894328 — TDX(R) LITES(TM) LITHIUM (November 13, 1989)
  • K830636 — POTASSIUM DILUENT (April 5, 1983)
  • K800039 — LITHIUM DILUENT (1500 MM/E) (January 21, 1980)

FDA data resources