FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOPLASMELISA TEST KIT
K Number: K823804
·
Decision May 25, 1983
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
12
Applicant Total
12
Review Days
159
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Basic Information
- Device Name
- MYCOPLASMELISA TEST KIT
- K Number
- K823804
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- M.A. Bioproducts
- Date Received
- December 17, 1982
- Decision Date
- May 25, 1983
- Product Code
- LJZ
- 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 |
|---|---|---|---|
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJZ), ordered by most recent decision date.
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
FDA 510(k)
FDA Class 1
·Microbiology
MYCOPLASMA IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
MYCOPLASMA IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
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MYCOPLASMA IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
FDA 510(k)
FDA Class 1
·Microbiology
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
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 |
| 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 |
| K812123 | CYTOMEGELISA TEST KIT | Sep 23, 1981 | Substantially Equivalent |
| K802508 | RUBELISA IGM TEST KIT | Dec 18, 1980 | Substantially Equivalent |