PMA P010007S014
- Device
- IMMULITE/IMMULITE 1000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S014
- Product code
- LOK
- Decision date
- 2021-04-28
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Modify resin used in manufacture of test unit cap/body.
Current openFDA PMA Record#
- Device
- IMMULITE/IMMULITE 1000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S014
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2021-04-28
- Decision code
- OK30
- Date received
- 2021-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify resin used in manufacture of test unit cap/body.