FDA PMA
FDA Class 1
Approved (Withdrawn)
🇺🇸 United States
Kit, Identification, Neisseria Gonorrhoeae
PMA: P770002
·
Decision Jul 18, 1979
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Kit, Identification, Neisseria Gonorrhoeae
- Trade Name
- GONOCOCCAL PILI ANTIBODY TEST
- PMA Number
- P770002
- Device Class
- FDA Class 1
- Product Code
- JSX
- Generic Name
- KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- July 18, 1979
- Date Received
- May 23, 1977
- Expedited Review
- N
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JSX | Kit, Identification, Neisseria Gonorrhoeae | FDA class 1 | Microbiology |