Home / 510(k) Clearances / K050338

510(k) K050338

MODIFICATION TO: INSTAREAD LITHIUM SYSTEM by Akers Biosciences, Inc. — Product Code JIH

K050338 is an FDA 510(k) premarket notification submitted by Akers Biosciences, Inc. for the device "MODIFICATION TO: INSTAREAD LITHIUM SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 2005. The device falls under product code JIH (Flame Photometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Akers Biosciences, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2005
Date Received
February 11, 2005
Clearance Type
Special
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 Biosciences, Inc.

  • K102338 — BREATHSCN PRO (January 12, 2011)
  • K062971 — BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS (December 18, 2006)
  • K060761 — BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS (April 28, 2006)
  • K052697 — HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL (January 4, 2006)

Other clearances for product code JIH

  • 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)
  • K771303 — FLAME PHOTOMETER MODEL 460 (August 22, 1977)

FDA data resources