FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
ROTA-STAT
K Number: K864811
·
Decision Aug 25, 1987
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
32
Applicant Total
4
Review Days
259
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Basic Information
- Device Name
- ROTA-STAT
- K Number
- K864811
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Diagnostic Laboratories, Ltd.
- Date Received
- December 9, 1986
- Decision Date
- August 25, 1987
- Product Code
- LIQ
- 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 |
|---|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | FDA class 1 | Microbiology |
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