510(k) K890689
- Device
- Adx Tm Opiates
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K890689
- Product code
- DGJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-25
- Date received
- 1989-02-14
- Regulation
- 866.5230
- Classification name
- Colostrum, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- MARY ZORC
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
Source Documents
510(k) summary PDF not indicated by FDA