510(k) K140455
- Device
- CAPTIA MEASLES IGM
- Applicant
- TRINITY BIOTECH USA
- 510(k) number
- K140455
- Product code
- PCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-22
- Date received
- 2014-02-24
- Regulation
- 866.3520
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bonnie B DeJoy
- Address
- 2823 Girts Rd. Jamestown NY US 14701 14701
FDA Registration Numbers#
- 1318354
- 2029372
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary