510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043460Substantially Equivalent

Olympus Lyophilized Chemistry Calibrators Dr0070 and Dr0071

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

K043460 is the FDA 510(k) clearance record for OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071, a class II device, cleared for Olympus America, Inc. on under FDA product code JIX (Calibrator, Multi-Analyte Mixture). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show one recall naming K043460.

Clearance record

Decision date
Received
(47 days to decision)
Product code
JIX Calibrator, Multi-Analyte Mixture
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Olympus America, Inc. 3131 W. Royal Ln., Irving TX
510(k) summary
Statement
Third party review
No

Clearances, product code JIX

Trailing 12 months

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

FDA records show no clearances under product code JIX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIX, 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