PMA P000021S043

Device: Dimension Vista TPSA Flex reagent cartridge
Applicant: Siemens Healthcare Diagnostics
PMA number: P000021
Supplement: S043
Product code: LTJ
Decision date: 2020-10-13
Generic name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Approval order statement: Qualification of a new supplier for the luminescent oxygen channeling immunoassay reaction vessel used on the Dimension Vista instrument

Current openFDA PMA Record#

Device: Dimension Vista TPSA Flex reagent cartridge
Applicant: Siemens Healthcare Diagnostics
PMA number: P000021
Supplement: S043
Product code: LTJ
Generic name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Decision date: 2020-10-13
Decision code: OK30
Date received: 2020-09-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of a new supplier for the luminescent oxygen channeling immunoassay reaction vessel used on the Dimension Vista instrument