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510(k) K042406

OLYMPUS LACTATE, OSR6193 by Olympus America, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2004
Date Received
September 3, 2004
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

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  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
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  • K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (November 29, 2006)
  • K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (October 5, 2006)

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  • K163544 — Lumipulse G Prolactin (January 12, 2017)
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