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510(k) K040508

VITALAB MAGNESIUM REAGENT by Clinical Data, Inc. — Product Code JGJ

K040508 is an FDA 510(k) premarket notification submitted by Clinical Data, Inc. for the device "VITALAB MAGNESIUM REAGENT". The FDA issued a decision of Substantially Equivalent on March 8, 2004. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Clinical Data, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2004
Date Received
February 27, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Clinical Data, Inc.

  • K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55 (December 20, 2007)
  • K052591 — NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT (February 9, 2006)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K040631 — VITALAB DIRECT BILIRUBIN REAGENT (March 18, 2004)
  • K040534 — VITALAB AMYLASE REAGENT (March 11, 2004)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT (November 3, 2003)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (June 17, 2003)

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)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)

FDA data resources