510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925093Substantially Equivalent

System 6300 Series High Performance Amino Acid Ana

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

K925093 is the FDA 510(k) clearance record for SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA, a class I device, cleared for Beckman Instruments, Inc. on under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K925093.

Clearance record

Decision date
Received
(405 days to decision)
Product code
JJF Analyzer, Chemistry, Micro, For Clinical Use
Regulation
21 CFR 862.2170
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Beckman Instruments, Inc. 1050 Page Mill Rd., Palo Alto CA
510(k) summary
Summary
Third party review
No

Clearances, product code JJF

Trailing 12 months

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

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