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510(k) K963139

OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT by Olympus America, Inc. — Product Code DDD

K963139 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT". The FDA issued a decision of Substantially Equivalent on February 6, 1997. The device falls under product code DDD (Transferrin, Rhodamine, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Olympus America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1997
Date Received
August 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Rhodamine, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

Other clearances by Olympus America, Inc.

  • K111788 — ENDOEYE HD II (January 13, 2012)
  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K073490 — OLYMPUS IGG REAGENT (February 11, 2008)
  • K073487 — OLYMPUS IGM REAGENT (February 11, 2008)
  • K073489 — OLYMPUS IGA REAGENT (February 11, 2008)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K061499 — OSFERION (January 26, 2007)
  • 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)

FDA data resources