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510(k) K070249

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H by Horiba Abx — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2007
Date Received
January 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • 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 CIC

  • K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (May 2, 2013)
  • K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (March 9, 2009)
  • K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (March 24, 2006)
  • K050077 — SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (February 15, 2005)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (March 13, 2003)
  • K013652 — WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (December 21, 2001)
  • K000375 — RANDOX CALCIUM (April 5, 2000)
  • K991111 — BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110 (May 25, 1999)
  • K971907 — CALCIUM REAGENT (June 24, 1997)