ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
FDA 510(k) clearance K220977 · decided 2023-07-20
Clearance details
- K-number
- K220977
- Device name
- ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
- Applicant
- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-04
- Decision date
- 2023-07-20
- Days to decision
- 472 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: recall (Z-2974-2026) | Beckman Coulter Inc. | 2026-08-17 |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 recall (Z-1784-2025) | Beckman Coulter Inc. | 2025-05-15 |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 recall (Z-1672-2025) | Beckman Coulter Inc. | 2025-04-25 |
| DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. recall (Z-1233-2025) | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. | 2025-02-25 |
| DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that recall (Z-2691-2024) | Beckman Coulter Mishima K.K. | 2024-08-21 |
| DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that recall (Z-2455-2024) | Beckman Coulter Mishima K.K. | 2024-07-31 |