FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDX BENZODIAZEPINES SERUM
K Number: K883730
·
Decision Nov 29, 1988
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
89
Applicant Total
857
Review Days
90
Basic Information
- Device Name
- TDX BENZODIAZEPINES SERUM
- K Number
- K883730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- ABBOTT LABORATORIES
- Date Received
- August 31, 1988
- Decision Date
- November 29, 1988
- Product Code
- JXM
- 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 |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | FDA class 2 | Clinical Toxicology |
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