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510(k) K031579

INSTAREAD LITHIUM SYSTEM by Akers Laboratories, Inc. — Product Code JIH

K031579 is an FDA 510(k) premarket notification submitted by Akers Laboratories, Inc. for the device "INSTAREAD LITHIUM SYSTEM". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code JIH (Flame Photometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Akers Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
May 20, 2003
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 Akers Laboratories, Inc.

  • K040293 — HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (May 28, 2004)
  • K030815 — AKERS LABORATORIES INC. BLOOD CELL SEPARATOR (September 17, 2003)

Other clearances for product code JIH

  • K050338 — MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (March 4, 2005)
  • 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)
  • K771303 — FLAME PHOTOMETER MODEL 460 (August 22, 1977)

FDA data resources