PMA P010007S011
- Device
- IMMULITE 2000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S011
- Product code
- LOK
- Decision date
- 2019-12-19
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Modify the resin used in manufacture of reaction tubes.
Current openFDA PMA Record#
- Device
- IMMULITE 2000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S011
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2019-12-19
- Decision code
- OK30
- Date received
- 2019-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the resin used in manufacture of reaction tubes.