FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOMEGALOVIRUS
K Number: K843657
·
Decision Sep 26, 1985
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
18
Applicant Total
16
Review Days
374
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
- CYTOMEGALOVIRUS
- K Number
- K843657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Institute Virion , Ltd.
- Date Received
- September 17, 1984
- Decision Date
- September 26, 1985
- Product Code
- GQH
- 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 |
|---|---|---|---|
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GQH), ordered by most recent decision date.
BARTELS CINAKIT CMV ANTIGENEMIA
FDA 510(k)
FDA Class 2
·Microbiology
CMV ANTIGEN CONTROL SLIDES
FDA 510(k)
FDA Class 2
·Microbiology
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
INDIRECT FLUORESCENT ASSAY FOR (HCMV)
FDA 510(k)
FDA Class 2
·Microbiology
FITC MURINE MONOCLONAL ANTI-CMV IGG
FDA 510(k)
FDA Class 2
·Microbiology
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Institute Virion , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | Sep 30, 1986 | Substantially Equivalent |
| K843665 | PARAINFLUENZA 1 | Sep 26, 1985 | Substantially Equivalent |
| K843649 | ADENOVIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843658 | H. SIMPLEX VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843662 | MEASLES VIRUS RUBEOLA | Sep 26, 1985 | Substantially Equivalent |
| K843667 | PARAINFLUENZA 3 | Sep 26, 1985 | Substantially Equivalent |
| K843660 | IN FLUENZA B VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843659 | INFLUENZA A2 VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843676 | VARICELLA/ZOSTER VIRUS | Sep 26, 1985 | Substantially Equivalent |