FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEM-T
K Number: K830497
·
Decision Apr 5, 1983
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
10
Applicant Total
4
Review Days
48
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Basic Information
- Device Name
- PEM-T
- K Number
- K830497
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hedeco
- Date Received
- February 16, 1983
- Decision Date
- April 5, 1983
- Product Code
- JWZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JWZ | Kit, Screening, Trichomonas | FDA class 1 | Microbiology |
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