PMA P970007S004
- Device
- IMX TACROLIMUS II
- Applicant
- Abbott Laboratories
- PMA number
- P970007
- Supplement
- S004
- Product code
- MLM
- Decision date
- 2002-09-05
- Classification
- Clinical Toxicology
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Approval order statement
- APPROVAL FOR THE ADDITION OF TESTING OF MODEL 1 CALIBRATOR TO VERIFY THE PROPER FILLING OF THE CALIBRATOR.
Current openFDA PMA Record#
- Device
- IMX TACROLIMUS II
- Applicant
- Abbott Laboratories
- PMA number
- P970007
- Supplement
- S004
- Product code
- MLM
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Decision date
- 2002-09-05
- Decision code
- APPR
- Date received
- 2001-07-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF TESTING OF MODEL 1 CALIBRATOR TO VERIFY THE PROPER FILLING OF THE CALIBRATOR.