FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
K Number: K932615
·
Decision Jul 14, 1993
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
883
Review Days
43
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Basic Information
- Device Name
- TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
- K Number
- K932615
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- June 1, 1993
- Decision Date
- July 14, 1993
- Product Code
- LAO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LAO | Enzyme Immunoassay, Methotrexate | FDA unclassified | Unknown |
Similar 510(k) Clearances
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ACA DU PONT METHOTREXATE (MTHO) METHOD
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FDA 510(k)
FDA Unclassified
·Unknown
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