510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934925Substantially Equivalent

Beckman Ammonia Amm Reagent/ Cx Ammonia Calibrator

Beckman Instruments, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934925 is the FDA 510(k) clearance record for BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR, a class I device, cleared for Beckman Instruments, Inc. on under FDA product code JIF (Enzymatic Method, Ammonia). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K934925.

Clearance record

Decision date
Received
(193 days to decision)
Product code
JIF Enzymatic Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337, Brea CA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260