FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K Number: K021526
·
Decision Jul 17, 2002
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
20
Applicant Total
85
Review Days
68
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Basic Information
- Device Name
- ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
- K Number
- K021526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3910
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- May 10, 2002
- Decision Date
- July 17, 2002
- Product Code
- LFG
- 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 |
|---|---|---|---|
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | FDA class 2 | Clinical Toxicology |
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