510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063804Substantially Equivalent

Olympus Triglyceride Test System

OLYMPUS Corporation of the Americas, Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063804 is the FDA 510(k) clearance record for OLYMPUS TRIGLYCERIDE TEST SYSTEM, a class I device, cleared for Olympus America, Inc. on under FDA product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show one recall naming K063804.

Clearance record

Decision date
Received
(91 days to decision)
Product code
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Regulation
21 CFR 862.1705
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Olympus America, Inc. 3131 W. Royal Ln., Irving TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDT

Trailing 12 months

FDA records hold no clearances under product code CDT in the trailing twelve months.

FDA records show no clearances under product code CDT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260