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510(k) K063208

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 by Diagnostic Chemicals , Ltd. — Product Code JGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2007
Date Received
October 23, 2006
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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  • K041926 — HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (November 23, 2004)
  • K041928 — HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (November 23, 2004)

Other clearances for product code JGJ

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  • 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)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)