FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTICONVULSANT CONTROL SERUM
K Number: K760730
·
Decision Oct 7, 1976
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
4
Review Days
10
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Basic Information
- Device Name
- ANTICONVULSANT CONTROL SERUM
- K Number
- K760730
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Reagents & Diagnostics, Inc.
- Date Received
- September 27, 1976
- Decision Date
- October 7, 1976
- Product Code
- LAS
- 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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | FDA class 1 | Clinical Toxicology |
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