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FDA 510(k)

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K-Number: K022177 · 2002-12-17

ApplicantBayer Diagnostics Corp.
Decision Date2002-12-17
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2002-12-17 under 510(k) number K022177. The device is classified under product code LTJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM?

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K022177.

When did PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM receive FDA 510(k) clearance?

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM received FDA 510(k) clearance on 2002-12-17, under 510(k) number K022177.

Who is the listed applicant for PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM?

The FDA 510(k) record lists Bayer Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM?

The FDA product code for PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM is LTJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Bayer Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033379BAYER SPECIAL CHEMISTRY CONTROLSK033380BAYER SPECIAL CHEMISTRY CALIBRATORSK033007BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMK031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYK022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMK030452BAYER LIGAND PLUS 1, 2, 3 CONTROLS

View all 32 devices →

Related Devices (Code: LTJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251630Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc.K162378FREND PSA PLUS (reagent cartridge)Nanoentek USA, Inc.K124056FREND PSA PLUS (REAGENT CARTRIDGE)Nanoentek, Inc.K031343TPSA FLEX REAGENT CARTRIDGEDade Behring, Inc.K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMBayer Corp.K010550VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428bioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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