510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K042015Substantially Equivalent

Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase

Bayer Healthcare, Diagnostics Division, Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042015 is the FDA 510(k) clearance record for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE, a class II device, cleared for Bayer Healthcare, Diagnostics Division on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 2 510(k) clearances for Bayer Healthcare, Diagnostics Division, from to . As of , FDA records show one recall naming K042015.

Clearance record

Decision date
Received
(64 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bayer Healthcare, Diagnostics Division 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CGA

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