510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895850Substantially Equivalent

Synchron Cx Systems (Lap) Reagent Kit

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

K895850 is the FDA 510(k) clearance record for SYNCHRON CX SYSTEMS (LAP) REAGENT KIT, a class I device, cleared for Beckman Instruments, Inc. on under FDA product code JGG (L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K895850.

Clearance record

Decision date
Received
(63 days to decision)
Product code
JGG L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
Regulation
21 CFR 862.1460
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337, Brea CA
Third party review
No

Clearances, product code JGG

Trailing 12 months

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

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