FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CYTOMEGELISA TEST KIT
K Number: K812123
·
Decision Sep 23, 1981
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
58
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Basic Information
- Device Name
- CYTOMEGELISA TEST KIT
- K Number
- K812123
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- M.A. Bioproducts
- Date Received
- July 27, 1981
- Decision Date
- September 23, 1981
- Advisory Committee
- Unknown
- Review Advisory Committee
- MI
- Third Party
- N
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 |
| K813221 | TOXOELISA TEST KIT | Jan 26, 1982 | Substantially Equivalent |
| K812531 | CELL CULTURE REAGENTS | Oct 23, 1981 | Substantially Equivalent |
| K802508 | RUBELISA IGM TEST KIT | Dec 18, 1980 | Substantially Equivalent |