FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
K Number: K121122
·
Decision Jul 3, 2012
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
- K Number
- K121122
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biochemical Diagnostic, Inc.
- Date Received
- April 13, 2012
- Decision Date
- July 3, 2012
- Product Code
- DIF
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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