FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOXOELISA TEST KIT
K Number: K813221
·
Decision Jan 26, 1982
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
12
Review Days
78
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Basic Information
- Device Name
- TOXOELISA TEST KIT
- K Number
- K813221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- M.A. Bioproducts
- Date Received
- November 9, 1981
- Decision Date
- January 26, 1982
- Product Code
- LGD
- 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
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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 |
| K830045 | MUMPSELISA TEST KIT | May 13, 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 |
| 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 |