FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SEKURE Acetaminophen L3K Assay
K Number: K180835
·
Decision Feb 8, 2019
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
6
Review Days
315
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Basic Information
- Device Name
- SEKURE Acetaminophen L3K Assay
- K Number
- K180835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Date Received
- March 30, 2018
- Decision Date
- February 8, 2019
- Product Code
- LDP
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDP), ordered by most recent decision date.
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ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
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Other Clearances by Sekisui Diagnostics P.E.I., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202644 | Acetaminophen | Feb 18, 2022 | Substantially Equivalent |
| K182702 | SEKURE Creatine Kinase Assay | Apr 17, 2019 | Substantially Equivalent |
| K173206 | SEKURE HbA1c Assay | Jul 12, 2018 | Substantially Equivalent |
| K163078 | DC-UIBC-CAL | Dec 8, 2016 | Substantially Equivalent |
| K111915 | MAGNESIUM ASSAY | Dec 2, 2011 | Substantially Equivalent |