FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TIF FECAL TEST
K Number: K873594
·
Decision Sep 29, 1987
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
3
Applicant Total
4
Review Days
25
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Basic Information
- Device Name
- TIF FECAL TEST
- K Number
- K873594
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Devetec, Inc.
- Date Received
- September 4, 1987
- Decision Date
- September 29, 1987
- Product Code
- LEA
- 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 |
|---|---|---|---|
| LEA | Preservative, Cytological | FDA class 1 | Pathology |
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