FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAKTERIETTE-VI-PAK
K Number: K840719
·
Decision Apr 4, 1984
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
1
Review Days
47
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Basic Information
- Device Name
- BAKTERIETTE-VI-PAK
- K Number
- K840719
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Great Lakes Intl.
- Date Received
- February 17, 1984
- Decision Date
- April 4, 1984
- Product Code
- JTW
- 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 |
|---|---|---|---|
| JTW | System, Transport, Aerobic | FDA class 1 | Microbiology |
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