FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO ORGANISM GROWTH SYS-M1000
K Number: K843000
·
Decision Feb 6, 1985
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
3
Review Days
191
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Basic Information
- Device Name
- MICRO ORGANISM GROWTH SYS-M1000
- K Number
- K843000
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hml Inc/Biotechnology Transfer
- Date Received
- July 30, 1984
- Decision Date
- February 6, 1985
- Product Code
- LIO
- 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | FDA class 1 | Microbiology |
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