510(k) K882534
- Device
- Abbott Testpack(tm) Gonorrhea Positive Control
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K882534
- Product code
- LIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-12
- Date received
- 1988-06-21
- Regulation
- 866.3390
- Classification name
- Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEAN FRYDMAN
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
Source Documents#
510(k) summary PDF not indicated by FDA