510(k) K902055
- Device
- Tenone(tm) Opiates Catalog: Vkso1,4
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K902055
- Product code
- DDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-10
- Date received
- 1990-05-07
- Regulation
- 866.5200
- Classification name
- Carbonic Anhydrase C, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- B ASARCH,PHD
- Address
- 5700 W. 96th St. Los Angeles CA US 90045 90045
Source Documents#
510(k) summary PDF not indicated by FDA