FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX ECSTASY (MDMA) ASSAY
K Number: K092275
·
Decision Mar 1, 2011
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
116
Review Days
581
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Basic Information
- Device Name
- RANDOX ECSTASY (MDMA) ASSAY
- K Number
- K092275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- July 28, 2009
- Decision Date
- March 1, 2011
- Product Code
- DKZ
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Nov 21, 2013 | Substantially Equivalent |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | Oct 23, 2013 | Substantially Equivalent |