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510(k) K173294

Magnesium by Abbott Laboratories — Product Code JGJ

K173294 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Magnesium". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2018
Date Received
October 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Magnesium
Device Class
Class I
Regulation Number
862.1495
Review Panel
CH
Submission Type

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Other clearances for product code JGJ

  • K181748 — Magnesium (September 12, 2018)
  • K162200 — Randox RX Daytona Plus Magnesium (MG) (April 28, 2017)
  • K162399 — Atellica CH Magnesium (Mg) (January 19, 2017)
  • K122302 — ACE MAGNESIUM REGENT (August 27, 2012)
  • K111915 — MAGNESIUM ASSAY (December 2, 2011)
  • K092737 — EASYRA MG REAGENT, MODEL 10220 (November 17, 2009)
  • K091910 — PICCOLO MAGNESIUM TEST SYSTEM (October 1, 2009)
  • K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (January 19, 2007)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)

FDA data resources