OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k) clearance K981743 · decided 1998-06-09
Clearance details
- K-number
- K981743
- Device name
- OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-18
- Decision date
- 1998-06-09
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- CKB
- Device class
- 2
- Regulation number
- 862.1020
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate am recall (Z-1907-2025) | Beckman Coulter Mishima K.K. | 2025-06-04 |
| ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer recall (Z-0152-2014) | Beckman Coulter Inc. | 2013-11-05 |
| ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automa recall (Z-0153-2014) | Beckman Coulter Inc. | 2013-11-05 |
| AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) recall (Z-0974-2012) | Beckman Coulter Inc. | 2012-02-07 |