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PMA P030040S017

Device
Atellica IM Hepatitis B core IgM (aHBcM) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P030040
Supplement
S017
Product code
LOM
Decision date
2020-04-03
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).

Current openFDA PMA Record#

Device
Atellica IM Hepatitis B core IgM (aHBcM) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P030040
Supplement
S017
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2020-04-03
Decision code
OK30
Date received
2020-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).