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510(k) K851657

DEMAND MAGNESIUM by Cooper Biomedical, Inc. — Product Code JGJ

K851657 is an FDA 510(k) premarket notification submitted by Cooper Biomedical, Inc. for the device "DEMAND MAGNESIUM". The FDA issued a decision of Substantially Equivalent on May 10, 1985. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Cooper Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1985
Date Received
April 23, 1985
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 Cooper Biomedical, Inc.

  • K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (February 13, 1987)
  • K863868 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (February 13, 1987)
  • K863301 — DEMAND TOTAL PROTEIN (September 26, 1986)
  • K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET (June 27, 1986)
  • K854130 — DEMAND ETHYL ALCOHOL (November 5, 1985)
  • K853949 — DEMAND ACID PHOSPHATASE REAGENT (October 16, 1985)
  • K852262 — ASSIST CLINICAL CHEMISTRY ANALYZER (June 25, 1985)
  • K851285 — RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI (June 17, 1985)
  • K851284 — RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM (June 11, 1985)
  • K851286 — RADIAL IMMUNODIFFUSION PLATES C3 & C4 (June 5, 1985)

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