FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
K Number: K220451
·
Decision Oct 5, 2023
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
18
Review Days
595
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Basic Information
- Device Name
- Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
- K Number
- K220451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Randox Laboratories Limited
- Date Received
- February 17, 2022
- Decision Date
- October 5, 2023
- Product Code
- DJG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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Other Clearances by Randox Laboratories Limited
| K Number | Device Name | ||
|---|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Jan 23, 2026 | Substantially Equivalent |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Oct 5, 2023 | Substantially Equivalent |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | Apr 21, 2017 | Substantially Equivalent |
| K161691 | Direct LDL Cholesterol (LDL) | Mar 20, 2017 | Substantially Equivalent |
| K152343 | Direct Bilirubin | Feb 16, 2016 | Substantially Equivalent |
| K152344 | Total Bilirubin | Jan 28, 2016 | Substantially Equivalent |
| K150819 | Triglycerides | Aug 6, 2015 | Substantially Equivalent |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | Dec 8, 2014 | Substantially Equivalent |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | Sep 18, 2014 | Substantially Equivalent |
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | May 22, 2014 | Substantially Equivalent |