FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MUMPSELISA TEST KIT
K Number: K830045
·
Decision May 13, 1983
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
7
Applicant Total
12
Review Days
123
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Basic Information
- Device Name
- MUMPSELISA TEST KIT
- K Number
- K830045
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- M.A. Bioproducts
- Date Received
- January 10, 1983
- Decision Date
- May 13, 1983
- Product Code
- LJY
- 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 |
|---|---|---|---|
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJY), ordered by most recent decision date.
MUMPS IGG ELISA TEST SYSTEM
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FDA 510(k)
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MUMPS IGG TEST
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MUMPS STAT
FDA 510(k)
FDA Class 1
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VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by M.A. Bioproducts
| K Number | Device Name | ||
|---|---|---|---|
| K822883 | HERPELISA KIT | Jul 26, 1983 | Substantially Equivalent |
| K823804 | MYCOPLASMELISA TEST KIT | May 25, 1983 | Substantially Equivalent |
| K830615 | CYTOMEGELISA STAT | May 9, 1983 | Substantially Equivalent |
| K823805 | VARICELISA TEST KIT | May 5, 1983 | Substantially Equivalent |
| K821967 | CHLAMYDELISA TEST KIT | Aug 3, 1982 | Substantially Equivalent |
| K821762 | MEASELISA TEST KIT | Jul 30, 1982 | Substantially Equivalent |
| K813221 | TOXOELISA TEST KIT | Jan 26, 1982 | Substantially Equivalent |
| K812531 | CELL CULTURE REAGENTS | Oct 23, 1981 | Substantially Equivalent |
| K812123 | CYTOMEGELISA TEST KIT | Sep 23, 1981 | Substantially Equivalent |
| K802508 | RUBELISA IGM TEST KIT | Dec 18, 1980 | Substantially Equivalent |