510(k) K801928
- Device
- Lab-tek Fta-abs Kit
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K801928
- Product code
- JWL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-20
- Date received
- 1980-08-12
- Regulation
- 866.3830
- Classification name
- Antigen, Treponema Pallidum For Fta-Abs Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005360469
Source Documents#
510(k) summary PDF not indicated by FDA