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.. Device class: 2.
Clearance details
- Applicant
- Genzyme Diagnostics P.E.I., 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
- Charlottetown, Prin Ed Island, CA
Recent devices under product code LDP
view allMore clearances from Genzyme Diagnostics P.E.I., Inc.
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 →
Recalls naming K081938
K-number listed on FDA's recall record- Z-3118-2017 — Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
- Z-1171-2016 — Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081938.
Data sourced from openFDA. This site is unofficial and independent of the FDA.