510(k) K863270
- Device
- Gene-trak Campylobacter Assay
- Applicant
- INTEGRATED GENETICS
- 510(k) number
- K863270
- Product code
- LQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-31
- Date received
- 1986-08-25
- Regulation
- 866.3110
- Classification name
- Dna-Reagents, Campylobacter Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KARENLEE VOLTZ-DOW
- Address
- 32 New York Ave. Framingham MA US 01701 01701
Source Documents#
510(k) summary PDF not indicated by FDA