FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XYLENE SUBSTITUTE MONTANT
K Number: K854083
·
Decision Oct 22, 1985
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
14
Applicant Total
5
Review Days
15
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Basic Information
- Device Name
- XYLENE SUBSTITUTE MONTANT
- K Number
- K854083
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Lerner Laboratories, Inc.
- Date Received
- October 7, 1985
- Decision Date
- October 22, 1985
- Product Code
- KEM
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KEM | Agent, Clearing | FDA class 1 | Pathology |
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