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510(k) K030015

ATAC PAK PHOSPHORUS REAGENT by Elan Diagnostics — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2003
Date Received
January 2, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
Review Panel
CH
Submission Type

Other clearances by Elan Diagnostics

  • K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR (September 29, 2003)
  • K030014 — ATAC TOTAL BILIRUBIN REAGENT (September 26, 2003)
  • K030621 — ATAC CALIBRATOR (March 19, 2003)
  • K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (March 13, 2003)
  • K030010 — ATAC PAK MAGNESIUM REAGENT (March 10, 2003)
  • K030006 — ATAC PAK ALBUMIN REAGENT (March 7, 2003)
  • K023407 — ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR (February 14, 2003)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K020575 — ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS (April 12, 2002)
  • K002285 — ATAC PAK ALP REAGENT KIT (September 26, 2000)

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  • K041643 — SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (August 18, 2004)
  • K022312 — PICCOLO PHOSPHORUS TEST SYSTEM (September 5, 2002)
  • K013095 — WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (November 16, 2001)
  • K003912 — PHOSPHORUS REAGENT (February 21, 2001)
  • K003012 — RAICHEM PHOSPORUS REAGENT (October 25, 2000)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (August 2, 1999)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K981769 — HICHEM PHOSPHORUS REAGENT KIT (June 29, 1998)