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510(k) K991761

MAGNESIUM PRODUCT NO'S, 112-01, 112-02 by A.P. Total Care, Inc. — Product Code JGJ

K991761 is an FDA 510(k) premarket notification submitted by A.P. Total Care, Inc. for the device "MAGNESIUM PRODUCT NO'S, 112-01, 112-02". The FDA issued a decision of Substantially Equivalent on September 2, 1999. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. A.P. Total Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1999
Date Received
May 24, 1999
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 A.P. Total Care, Inc.

  • K991246 — FRUCTOSAMINE, MODEL FR 106-01 (December 16, 1999)
  • K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (September 2, 1999)
  • K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (August 19, 1999)
  • K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (August 10, 1999)
  • K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (August 2, 1999)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (August 2, 1999)
  • K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 (July 30, 1999)
  • K991663 — AST/SGOT (June 30, 1999)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (June 30, 1999)
  • K990981 — GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101- (May 25, 1999)

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