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510(k) K123171

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT by HORIBA ABX SAS — Product Code CJY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 3, 2013
Date Received: October 9, 2012
Clearance Type: Abbreviated
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

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K192028 — Yumizen C1200 CRP (June 25, 2020)
K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Fact (March 6, 2020)
K191993 — Yumizen C1200 CRP (October 3, 2019)
K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin (August 30, 2019)
K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (July 26, 2019)
K170353 — ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (November 1, 2017)
K151133 — PENTRA XLR (December 9, 2015)

Other clearances for product code CJY

K244042 — Calcium2 (February 10, 2025)
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)
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)
K072440 — VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL (September 20, 2007)