510(k) K082612
- Device
- GBS PNA FISH
- Applicant
- Advandx, Inc.
- 510(k) number
- K082612
- Product code
- OAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-05
- Date received
- 2008-09-09
- Regulation
- 866.3740
- Classification name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULA E BULGER
- Address
- 10a Roessler Rd. Woburn MA US 01801 01801
Source Documents#
510(k) summary PDF not indicated by FDA