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510(k) K863069

MAGNESIOMETER by J. D. Assoc. — Product Code JGJ

K863069 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "MAGNESIOMETER". The FDA issued a decision of Substantially Equivalent on December 31, 1986. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. J. D. Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1986
Date Received
August 12, 1986
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 J. D. Assoc.

  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863103 — PEG 6,000 (January 13, 1987)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863102 — GLUCOMETER-E (November 24, 1986)
  • K863109 — FERROFAST (November 24, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)

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