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FDA 510(k)

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

K-Number: K010550 · 2001-04-24

ApplicantbioMerieux, Inc.
Decision Date2001-04-24
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2001-04-24 under 510(k) number K010550. 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 VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428?

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 is a medical device that received FDA 510(k) clearance on 2001-04-24. The listed applicant is bioMerieux, Inc.. The 510(k) number is K010550.

When did VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 receive FDA 510(k) clearance?

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 received FDA 510(k) clearance on 2001-04-24, under 510(k) number K010550.

Who is the listed applicant for VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428?

The FDA product code for VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 is LTJ.

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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.K022177PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMBayer Corp.

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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