PMA P970007S001
- Device
- ABBOTT IMX TACROLIMUS II
- Applicant
- Abbott Laboratories
- PMA number
- P970007
- Supplement
- S001
- Product code
- MLM
- Decision date
- 1999-09-22
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Approval order statement
- Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.
Current openFDA PMA Record#
- Device
- ABBOTT IMX TACROLIMUS II
- Applicant
- Abbott Laboratories
- PMA number
- P970007
- Supplement
- S001
- Product code
- MLM
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Decision date
- 1999-09-22
- Decision code
- APPR
- Date received
- 1999-09-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.