510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K161837Substantially Equivalent

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

Siemens Healthcare Diagnostics Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161837 is the FDA 510(k) clearance record for ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K161837.

Clearance record

Decision date
Received
(164 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Beckman Coulter, Inc. 250 S. Kraemer Blvd. Mails Stop E1.Se.01, Brea CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JGS

Trailing 12 months
1 clearance under product code JGS in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JGS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260