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510(k) K952466

OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT by Olympus America, Inc. — Product Code JHN

K952466 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT". The FDA issued a decision of Substantially Equivalent on June 5, 1995. The device falls under product code JHN (Turbidimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Olympus America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1995
Date Received
May 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric Method, Lipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
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)
  • K073489 — OLYMPUS IGA REAGENT (February 11, 2008)
  • K073487 — OLYMPUS IGM 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)

Other clearances for product code JHN

  • K950383 — APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT (September 15, 1995)
  • K950382 — APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT (September 15, 1995)
  • K952615 — WAKO AUTOKIT APO A1 (September 8, 1995)
  • K952425 — OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT (July 5, 1995)
  • K932606 — APOLIPOPROTIEN A-1 (APO A-1) (June 2, 1994)
  • K932603 — APOLIPOPROTIEN B (APO B) (June 2, 1994)

FDA data resources