510(k) K900455
- Device
- Zefazone Susceptibility Powder
- Applicant
- THE UPJOHN CO.
- 510(k) number
- K900455
- Product code
- LOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-09
- Date received
- 1990-01-30
- Regulation
- 866.1640
- Classification name
- Solution, Antimicrobial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MASON, PH.D.
- Address
- 7000 Portage Rd. Kalamazoo MI US 49001 49001
Source Documents#
510(k) summary PDF not indicated by FDA