FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROMCHECK SPECIMEN COLLECTION KIT
K Number: K900225
·
Decision Feb 2, 1990
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
3
Review Days
16
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Basic Information
- Device Name
- ROMCHECK SPECIMEN COLLECTION KIT
- K Number
- K900225
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Adeza Biomedical
- Date Received
- January 17, 1990
- Decision Date
- February 2, 1990
- 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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