FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM N-ACETYLPROCAINAMIDE
K Number: K955422
·
Decision Apr 24, 1996
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
20
Applicant Total
883
Review Days
148
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Basic Information
- Device Name
- AXSYM N-ACETYLPROCAINAMIDE
- K Number
- K955422
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- November 28, 1995
- Decision Date
- April 24, 1996
- Product Code
- LAN
- 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 |
|---|---|---|---|
| LAN | Enzyme Immunoassay, N-Acetylprocainamide | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LAN), ordered by most recent decision date.
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NAPA EIA ASSAY
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FDA 510(k)
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·Clinical Toxicology
OPUS NAPA
FDA 510(k)
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