510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990346Substantially Equivalent

Bayer Advia 1650 Chemistry System

Bayer Corp., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990346 is the FDA 510(k) clearance record for BAYER ADVIA 1650 CHEMISTRY SYSTEM, a class II device, cleared for Bayer Corp. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 63 510(k) clearances for Bayer Corp., from to . As of , FDA records show 14 recalls naming K990346.

Clearance record

Decision date
Received
(106 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bayer Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code JGS

Trailing 12 months
1 clearance under product code JGS 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 JGS, 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