FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROTAVIRUS BIO-ENZABEAD SCREEN KIT
K Number: K834443
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
32
Applicant Total
15
Review Days
91
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Basic Information
- Device Name
- ROTAVIRUS BIO-ENZABEAD SCREEN KIT
- K Number
- K834443
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Litton Bionetics
- Date Received
- December 16, 1983
- Decision Date
- March 16, 1984
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIQ), ordered by most recent decision date.
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ROTA-DAN RAPID ROTAVIRUS EIA KIT
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Other Clearances by Litton Bionetics
| K Number | Device Name | ||
|---|---|---|---|
| K840417 | EBNA ACIF KIT | Dec 27, 1984 | Substantially Equivalent |
| K831343 | CMV RQ BIO-ENZABEAD KIT | Aug 8, 1983 | Substantially Equivalent |
| K822985 | EBV-M KIT | Dec 3, 1982 | Substantially Equivalent |
| K821804 | RUBELLA RQ BIO-ENZABEAD KIT | Sep 14, 1982 | Substantially Equivalent |
| K801720 | TOXO BIO-BEAD TITRATION KIT | Sep 16, 1980 | Substantially Equivalent |
| K801721 | HSV BIO-BEAD TITRATION KIT | Sep 16, 1980 | Substantially Equivalent |
| K801722 | CMV BIO-BEAD TITRATION KIT | Sep 16, 1980 | Substantially Equivalent |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | Jun 30, 1980 | Substantially Equivalent |
| K791611 | TOXO BIO-BEAD SCREEN KIT | Nov 13, 1979 | Substantially Equivalent |
| K791610 | RUBELLA BIO-BEAD SCREEN KIT | Nov 13, 1979 | Substantially Equivalent |