FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REVISED LABELING FOR TDX CANNABINOIDS
K Number: K874488
·
Decision Nov 23, 1987
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
149
Applicant Total
857
Review Days
24
Basic Information
- Device Name
- REVISED LABELING FOR TDX CANNABINOIDS
- K Number
- K874488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- ABBOTT LABORATORIES
- Date Received
- October 30, 1987
- Decision Date
- November 23, 1987
- Product Code
- LDJ
- 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 |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | FDA class 2 | Clinical Toxicology |
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