FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
K Number: K132090
·
Decision Aug 8, 2013
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
122
Applicant Total
116
Review Days
27
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Basic Information
- Device Name
- BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
- K Number
- K132090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- July 12, 2013
- Decision Date
- August 8, 2013
- Product Code
- DLJ
- 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 |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | FDA class 2 | Clinical Toxicology |
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