FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL
K Number: K803133
·
Decision Jan 29, 1981
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
14
Review Days
48
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Basic Information
- Device Name
- RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL
- K Number
- K803133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Microbiological Research Corp.
- Date Received
- December 12, 1980
- Decision Date
- January 29, 1981
- 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 Microbiological Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Apr 26, 1989 | Substantially Equivalent |
| K861121 | THE GOLDEN QUAD TEST (EBV) | Feb 2, 1987 | Substantially Equivalent |
| K861123 | THE GOLDEN QUAD TEST (CMV) | Feb 2, 1987 | Substantially Equivalent |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Feb 2, 1987 | Substantially Equivalent |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Feb 2, 1987 | Substantially Equivalent |
| K860450 | THE CMV-IGM TEST | May 13, 1986 | Substantially Equivalent |
| K843138 | CMV TEST | Jan 29, 1985 | Substantially Equivalent |
| K821018 | ANTIHUMAN IGG GLOBULIN FITC LABELED | Apr 29, 1982 | Substantially Equivalent |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Apr 26, 1982 | Substantially Equivalent |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Jan 29, 1981 | Substantially Equivalent |