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FDA 510(k)

TOTAL PSA MICROTITER ELISA

K-Number: K002121 · 2000-08-30

ApplicantOncogene Science, Inc.
Decision Date2000-08-30
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TOTAL PSA MICROTITER ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Oncogene Science, Inc.. It received FDA 510(k) clearance on 2000-08-30 under 510(k) number K002121. 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 TOTAL PSA MICROTITER ELISA?

TOTAL PSA MICROTITER ELISA is a medical device that received FDA 510(k) clearance on 2000-08-30. The listed applicant is Oncogene Science, Inc.. The 510(k) number is K002121.

When did TOTAL PSA MICROTITER ELISA receive FDA 510(k) clearance?

TOTAL PSA MICROTITER ELISA received FDA 510(k) clearance on 2000-08-30, under 510(k) number K002121.

Who is the listed applicant for TOTAL PSA MICROTITER ELISA?

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

What is the FDA product code for TOTAL PSA MICROTITER ELISA?

The FDA product code for TOTAL PSA MICROTITER ELISA is LTJ.

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Other records listing Oncogene Science, 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.

K994112MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)K002313COMPLEXED PSA MICROTITER ELISA

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

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

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