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510(k) K981854

OLYMPUS SERUM PROTEIN MULTICALIBRATOR, by Olympus Diagnostica GmbH — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1998
Date Received
May 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
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)
  • K982035 — OLYMPUS CALCIUM ARSENAZO III REAGENT (June 24, 1998)

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