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510(k) K895465

AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE by Baxter Healthcare Corp — Product Code JIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1989
Date Received
September 11, 1989
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

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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)
  • K894328 — TDX(R) LITES(TM) LITHIUM (November 13, 1989)
  • K830636 — POTASSIUM DILUENT (April 5, 1983)
  • K800039 — LITHIUM DILUENT (1500 MM/E) (January 21, 1980)
  • K771303 — FLAME PHOTOMETER MODEL 460 (August 22, 1977)