SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO— 510(k) K011465
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K011465 for SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO, Substantially Equivalent on 2001-06-08. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code LDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3030
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brea, CA, US
Recent devices under product code LDP
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view allAdverse events under product code LDP
product code LDP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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