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FDA 510(k)

PROSTATE SPECIFIC ANTIGEN METHOD

K-Number: K973101 · 1997-09-18

ApplicantDade Chemistry Systems, Inc.
Decision Date1997-09-18
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PROSTATE SPECIFIC ANTIGEN METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Dade Chemistry Systems, Inc.. It received FDA 510(k) clearance on 1997-09-18 under 510(k) number K973101. 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 METHOD?

PROSTATE SPECIFIC ANTIGEN METHOD is a medical device that received FDA 510(k) clearance on 1997-09-18. The listed applicant is Dade Chemistry Systems, Inc.. The 510(k) number is K973101.

When did PROSTATE SPECIFIC ANTIGEN METHOD receive FDA 510(k) clearance?

PROSTATE SPECIFIC ANTIGEN METHOD received FDA 510(k) clearance on 1997-09-18, under 510(k) number K973101.

Who is the listed applicant for PROSTATE SPECIFIC ANTIGEN METHOD?

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

What is the FDA product code for PROSTATE SPECIFIC ANTIGEN METHOD?

The FDA product code for PROSTATE SPECIFIC ANTIGEN METHOD is LTJ.

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Other records listing Dade Chemistry Systems, Inc. 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.

K973650TROPONIN (TROP) METHODK973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORK973099PROSTATE SPECIFIC ANTIGEN CONTROLK971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMK970387HUMAN CHORIONIC GONADOTROPIN METHODK970336MMB CALIBRATOR

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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.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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