OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k) clearance K011720 · decided 2001-06-25
Clearance details
- K-number
- K011720
- Device name
- OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-04
- Decision date
- 2001-06-25
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- CIX
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus America
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 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 |
| AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated an recall (Z-1430-2013) | Beckman Coulter Inc. | 2013-05-29 |
| AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) recall (Z-0974-2012) | Beckman Coulter Inc. | 2012-02-07 |
| AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU recall (Z-0977-2012) | Beckman Coulter Inc. | 2012-02-07 |