510(k) K220977 ยท JGS Electrode, Ion Specific, Sodium
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
| Applicant | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jul 20, 2023 |
| Received | Apr 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220977
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | Beckman Coulter Inc. DxC 500 AU Clinical Chemistry Analyzers:
1. AU w/out ISE, Part No. C63519
2. AU w/ISE, Part No. C63520 Open, Classified |
JJE | None listed |
| Aug 17, 2026 | Beckman Coulter Inc. Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower:
1) AU w/out ISE, Part Number C63519;
2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyze Open, Classified |
JJE | None listed |
| May 15, 2025 | Beckman Coulter Inc. DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:
C63519 / 14987666545058
C63520 / 14987666545065.
The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistr Open, Classified |
JJE | None listed |
| Apr 25, 2025 | Beckman Coulter Inc. DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:
C63519 / 14987666545058
C63520 / 14987666545065
Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3
The Beckman Coulter DxC 500 A Open, Classified |
JJE | None listed |
| Feb 25, 2025 | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. Open, Classified |
JJE | None listed |
| Aug 21, 2024 | Beckman Coulter Mishima K.K. DxC 500 AU Clinical Chemistry Analyzer, REF C63520
is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) ma Open, Classified |
JJE | None listed |
| Jul 31, 2024 | Beckman Coulter Mishima K.K. DxC 500 AU Clinical Chemistry Analyzer, REF C63520
is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) ma Open, Classified |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.