SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT— 510(k) K000494
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K000494 for SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT, Substantially Equivalent on 2000-04-14. 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
- Traditional
- 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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