Home / 510(k) Clearances / K030010

510(k) K030010

ATAC PAK MAGNESIUM REAGENT by Elan Diagnostics — Product Code JGJ

K030010 is an FDA 510(k) premarket notification submitted by Elan Diagnostics for the device "ATAC PAK MAGNESIUM REAGENT". The FDA issued a decision of Substantially Equivalent on March 10, 2003. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Elan Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2003
Date Received
January 2, 2003
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

Other clearances by Elan Diagnostics

  • K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR (September 29, 2003)
  • K030014 — ATAC TOTAL BILIRUBIN REAGENT (September 26, 2003)
  • K030621 — ATAC CALIBRATOR (March 19, 2003)
  • K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (March 13, 2003)
  • K030006 — ATAC PAK ALBUMIN REAGENT (March 7, 2003)
  • K030015 — ATAC PAK PHOSPHORUS REAGENT (March 7, 2003)
  • K023407 — ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR (February 14, 2003)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K020575 — ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS (April 12, 2002)
  • K002285 — ATAC PAK ALP REAGENT KIT (September 26, 2000)

Other clearances for product code JGJ

  • K181748 — Magnesium (September 12, 2018)
  • K173294 — Magnesium (May 18, 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)

FDA data resources