510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021151Substantially Equivalent

Ammonia Assay for the Advia Integrated Modular System

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

K021151 is the FDA 510(k) clearance record for AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, a class I device, cleared for Bayer Diagnostics Corp. on under FDA product code JIF (Enzymatic Method, Ammonia). FDA records list 32 510(k) clearances for Bayer Diagnostics Corp., from to . As of , FDA records show no recalls naming K021151.

Clearance record

Decision date
Received
(94 days to decision)
Product code
JIF Enzymatic Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bayer Diagnostics Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIF

Trailing 12 months

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

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