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510(k) K902476

CALCIUM:ARSENAZO III by Amresco, Inc. — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1990
Date Received
June 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Amresco, Inc.

  • K905618 — GGT REAGENT (February 26, 1991)
  • K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 (January 17, 1991)
  • K905684 — ALKALINE PHOSPHATASE (December 28, 1990)
  • K905544 — MAGNESIUM REAGENT (December 27, 1990)
  • K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 (December 11, 1990)
  • K905284 — HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (December 11, 1990)
  • K905096 — GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 (November 28, 1990)
  • K904381 — DIAZO COLORIMENTRY DIRECT BILIRUBIN (October 12, 1990)
  • K903775 — CREATINE PHOSPHOKINASE (October 4, 1990)
  • K903829 — AST REAGENT (September 25, 1990)

Other clearances for product code CJY

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  • K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (July 26, 2019)
  • K182042 — Randox Calcium (Ca) (October 23, 2018)
  • K151113 — ELITech Clinical Systems CALCIUM ARSENAZO (July 22, 2015)
  • K123171 — ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX (July 3, 2013)
  • K120626 — EON CALCIUM REGENT (August 22, 2012)
  • K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 0 (April 2, 2009)
  • K072356 — S-TEST CA (June 24, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (September 24, 2007)