510(k) K834067
- Device
- Legionella Differentiation Disk
- Applicant
- REMEL CO.
- 510(k) number
- K834067
- Product code
- GRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-03
- Date received
- 1983-11-25
- Regulation
- 866.3300
- Classification name
- Antisera, Fluorescent, All Types, Hemophilus Spp.
- 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
Source Documents#
510(k) summary PDF not indicated by FDA