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510(k) K982035

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

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)

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