510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220977Substantially Equivalent

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220977 is the FDA 510(k) clearance record for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer, a class II device, cleared for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 2 510(k) clearances for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., from to . As of , FDA records show 6 recalls naming K220977.

Clearance record

Decision date
Received
(472 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 Laboratory Systems (Suzhou) Co., Ltd. # 181 W. Su Hong Rd., Suzhou Industrial Park, Suzhou, CN
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