FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOMEGELISA STAT
K Number: K830615
·
Decision May 9, 1983
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
57
Applicant Total
12
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CYTOMEGELISA STAT
- K Number
- K830615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- M.A. Bioproducts
- Date Received
- February 28, 1983
- Decision Date
- May 9, 1983
- Product Code
- LFZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFZ), ordered by most recent decision date.
Architect CMV IgG
FDA 510(k)
FDA Class 2
·Microbiology
Elecsys CMV IgG
FDA 510(k)
FDA Class 2
·Microbiology
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
FDA 510(k)
FDA Class 2
·Microbiology
Elecsys CMV IgM
FDA 510(k)
FDA Class 2
·Microbiology
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
FDA 510(k)
FDA Class 2
·Microbiology
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
FDA 510(k)
FDA Class 2
·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 |
| K830045 | MUMPSELISA TEST KIT | May 13, 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 |