FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
K Number: K904095
·
Decision Feb 1, 1991
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
36
Applicant Total
4
Review Days
148
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
- HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
- K Number
- K904095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- California Integrated Diagnostics, Inc.
- Date Received
- September 6, 1990
- Decision Date
- February 1, 1991
- Product Code
- GQL
- 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 |
|---|---|---|---|
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GQL), ordered by most recent decision date.
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
FDA 510(k)
FDA Class 2
·Microbiology
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
FDA 510(k)
FDA Class 2
·Microbiology
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
FDA 510(k)
FDA Class 2
·Microbiology
INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
FDA 510(k)
FDA Class 2
·Microbiology
PATHODX HERPES TYPING
FDA 510(k)
FDA Class 2
·Microbiology