PMA P930027S020

Device

IMMULITE/IMMULITE 1000 PSA and IMMULITE 2000 PSA AND 1000 Third Generation PSA

Applicant

Siemens Healthcare Diagnostics, Inc.

PMA number

P930027

Supplement

S020

Product code

MTF

Decision date

2018-12-27

Classification

Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer

Generic name

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Approval order statement

Approval for labeling changes describing the impact of endogenous biotin.

Summary

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