510(k) K802423
- Device
- Phadebact Haemophilus Test
- Applicant
- PHARMACIA, INC.
- 510(k) number
- K802423
- Product code
- GRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-11-12
- Date received
- 1980-10-03
- 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
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA