PMA P890019
- Device
- ETI-AB-HAVK PLUS
- Applicant
- Diasorin
- PMA number
- P890019
- Supplement
- S005
- Product code
- LOL
- Decision date
- 2005-12-12
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Approval order statement
- APPROVAL FOR CHANGE IN THE MANUFACTURING PROCESS FOR THE NEUTRALIZING SOLUTION (HAV REAGENT).
Current openFDA PMA Record
- Device
- ETI-AB-HAVK PLUS
- Applicant
- Diasorin
- PMA number
- P890019
- Supplement
- S012
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 2005-12-12
- Decision code
- APPR
- Date received
- 2005-11-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGE IN THE MANUFACTURING PROCESS FOR THE NEUTRALIZING SOLUTION (HAV REAGENT).