510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080435Substantially Equivalent

Olympus Direct Bilirubin Reagent, Model Osr6x181

Olympus Life Science Research Europa GmbH (Europa), Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K080435 is the FDA 510(k) clearance record for OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181, a class II device, cleared for Olympus Life Science Research Europa GmbH (Europa) on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 3 510(k) clearances for Olympus Life Science Research Europa GmbH (Europa), from to . As of , FDA records show no recalls naming K080435.

Clearance record

Decision date
Received
(199 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Olympus Life Science Research Europa GmbH (Europa) 3500 Corporate Pkway, Center Valley PA
510(k) summary
Statement
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260