PMA P890014S007
- Device
- DIASORIN ETI-HA-IGMK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P890014
- Supplement
- S007
- Product code
- LOL
- Decision date
- 2005-06-22
- Classification
- Microbiology
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Approval order statement
- CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- DIASORIN ETI-HA-IGMK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P890014
- Supplement
- S007
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 2005-06-22
- Decision code
- OK30
- Date received
- 2005-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.