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510(k) K930074

IN-VITRO DIAGNOSTIC REAGENT SET by Horizon Diagnostics, Inc. — Product Code JGJ

K930074 is an FDA 510(k) premarket notification submitted by Horizon Diagnostics, Inc. for the device "IN-VITRO DIAGNOSTIC REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 11, 1993. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Horizon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1993
Date Received
January 7, 1993
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 Horizon Diagnostics, Inc.

  • K971566 — CREATINE KINASE-MB REAGENT SET (July 14, 1997)
  • K933722 — HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (June 13, 1996)
  • K935712 — IRON/TIBC REAGENT (September 20, 1995)
  • K930678 — AMYLASE (April 6, 1994)
  • K934533 — BUN-300/BUN-500 UREA NITROGEN REAGENT (November 26, 1993)
  • K930679 — DIRECT BILIRUBIN (June 29, 1993)

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