FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUBELLA RQ BIO-ENZABEAD KIT
K Number: K821804
·
Decision Sep 14, 1982
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
15
Review Days
89
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Basic Information
- Device Name
- RUBELLA RQ BIO-ENZABEAD KIT
- K Number
- K821804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Litton Bionetics
- Date Received
- June 17, 1982
- Decision Date
- September 14, 1982
- Product Code
- LFX
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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Other Clearances by Litton Bionetics
| K Number | Device Name | ||
|---|---|---|---|
| K840417 | EBNA ACIF KIT | Dec 27, 1984 | Substantially Equivalent |
| K834443 | ROTAVIRUS BIO-ENZABEAD SCREEN KIT | Mar 16, 1984 | Substantially Equivalent |
| K831343 | CMV RQ BIO-ENZABEAD KIT | Aug 8, 1983 | Substantially Equivalent |
| K822985 | EBV-M KIT | Dec 3, 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 |