FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS
K Number: K920222
·
Decision Jul 27, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
11
Applicant Total
3
Review Days
193
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
- HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS
- K Number
- K920222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Akers Research Corp.
- Date Received
- January 16, 1992
- Decision Date
- July 27, 1992
- Product Code
- LJO
- 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 |
|---|---|---|---|
| LJO | Antigen, Iha, Cytomegalovirus | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJO), ordered by most recent decision date.
Capture-CMV
FDA 510(k)
FDA Class 2
·Microbiology
Capture-CMV
FDA 510(k)
FDA Class 2
·Microbiology
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
HYBRID CAPTURE SYSTEM CMV DNA ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
CMVGEN
FDA 510(k)
FDA Class 2
·Microbiology
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
FDA 510(k)
FDA Class 2
·Microbiology