FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SNAP(R) ROTAVIRUS DIAGNOSTIC KIT
K Number: K873565
·
Decision May 13, 1988
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
4
Review Days
254
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Basic Information
- Device Name
- SNAP(R) ROTAVIRUS DIAGNOSTIC KIT
- K Number
- K873565
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Molecular Biosystems, Inc.
- Date Received
- September 2, 1987
- Decision Date
- May 13, 1988
- 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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