ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30— 510(k) K081938
Substantially EquivalentGenzyme Diagnostics P.E.I., Inc.
FDA 510(k) clearance K081938 for ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30, Substantially Equivalent on 2009-05-01. Applicant: Genzyme Diagnostics P.E.I., Inc..
Clearance details
- Applicant
- Genzyme Diagnostics P.E.I., Inc.
- Product code
- Code LDP
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown, Prin Ed Island, CA
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.