FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROTAVIRUS ENZYME IMMUNOASSAY
K Number: K843367
·
Decision Jun 13, 1985
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
32
Applicant Total
4
Review Days
289
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Basic Information
- Device Name
- ROTAVIRUS ENZYME IMMUNOASSAY
- K Number
- K843367
- 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
- August 28, 1984
- Decision Date
- June 13, 1985
- Product Code
- LIQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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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