FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REVISED LABELING FOR ADX OPIATES
K Number: K880010
·
Decision Feb 11, 1988
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
883
Review Days
38
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Basic Information
- Device Name
- REVISED LABELING FOR ADX OPIATES
- K Number
- K880010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- January 4, 1988
- Decision Date
- February 11, 1988
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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