510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K897183Substantially Equivalent

Synchron El-Ise(tm) Electrolyte Systems

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

K897183 is the FDA 510(k) clearance record for SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS, a class II device, cleared for Beckman Instruments, Inc. on under FDA product code JFL (Ph Rate Measurement, Carbon-Dioxide). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K897183.

Clearance record

Decision date
Received
(92 days to decision)
Product code
JFL Ph Rate Measurement, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337, Brea CA
Third party review
No

Clearances, product code JFL

Trailing 12 months

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

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