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FDA 510(k)

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K-Number: K980376 · 1998-04-23

ApplicantBayer Corp.
Decision Date1998-04-23
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1998-04-23 under 510(k) number K980376. 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 THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Bayer Corp.. The 510(k) number is K980376.

When did THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM receive FDA 510(k) clearance?

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM received FDA 510(k) clearance on 1998-04-23, under 510(k) number K980376.

Who is the listed applicant for THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

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

What is the FDA product code for THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

The FDA product code for THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is LTJ.

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Other records listing Bayer 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

View all 96 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.K022177PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics 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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