510(k) K092393
- Device
- EK/P. AERUGINOSA PNA FISH
- Applicant
- Advandx, Inc.
- 510(k) number
- K092393
- Product code
- JSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-09-01
- Date received
- 2009-08-05
- Regulation
- 866.2660
- Classification name
- Kit, Identification, Enterobacteriaceae
- 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
FDA Registration Numbers#
- 9615755
- 9680577
- 3009171251
- 9615754
- 1924669
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
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