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510(k) K982035

OLYMPUS CALCIUM ARSENAZO III REAGENT by Olympus Diagnostica GmbH — Product Code CJY

K982035 is an FDA 510(k) premarket notification submitted by Olympus Diagnostica GmbH for the device "OLYMPUS CALCIUM ARSENAZO III REAGENT". The FDA issued a decision of Substantially Equivalent on June 24, 1998. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Olympus Diagnostica GmbH has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1998
Date Received
June 10, 1998
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 Olympus Diagnostica GmbH

  • K994189 — OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 (January 20, 2000)
  • K984145 — OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT (December 23, 1998)
  • K981854 — OLYMPUS SERUM PROTEIN MULTICALIBRATOR, (August 18, 1998)

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)
  • 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)

FDA data resources