ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
FDA 510(k) clearance K081938 · decided 2009-05-01
Clearance details
- K-number
- K081938
- Device name
- ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
- Applicant
- Genzyme Diagnostics P.E.I., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-08
- Decision date
- 2009-05-01
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Charlottetown, Prin Ed Island, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.