Complexed Psa Microtiter Elisa

FDA 510(k) K002313 · Oncogene Science, Inc.

Substantially Equivalent

510(k) numberK002313

Submission

Device name
Complexed Psa Microtiter Elisa
Applicant
Oncogene Science, Inc.
Cambridge, MA, US
Received
July 31, 2000
Decision date
August 30, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LTJ – Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Specialty
Immunology

Other 510(k)s with product code LTJ

510(k)DeviceApplicantDecision
K251630Atellica IM Total PSA II (tPSAII)LTJ · Traditional Siemens Healthcare Diagnostics, Inc.01/05/2026SE
K162378FREND PSA PLUS (reagent cartridge)LTJ · Traditional Nanoentek USA, Inc.05/17/2017SE
K124056Frend Psa Plus (Reagent Cartridge)LTJ · Traditional Nanoentek, Inc.05/29/2013SE
K031343Tpsa Flex Reagent CartridgeLTJ · Special Dade Behring, Inc.05/15/2003SE
K022288Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module…LTJ · Traditional Bayer Corp.12/17/2002SE
K022177Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional Bayer Diagnostics Corp.12/17/2002SE
K010550Vidas Total Prostate Specific Antigen (Tpsa), Model 30 428LTJ · Traditional bioMerieux, Inc.04/24/2001SE
K003963Dimension Psa Flex Reagent CartridgeLTJ · Traditional Dade Behring, Inc.02/28/2001SE
K002376Advia: Centaur and Acs: 180 Cpsa AssayLTJ · Traditional Bayer Corp.10/26/2000SE
K003094Fastpack Psa Immunoassay, Fastpack AnalyzerLTJ · Special Qualigen, Inc.10/25/2000SE

More from Qualigen, Inc.

510(k)DeviceDecision
K994112Manual HER-2/NEU Microtiter Elisa (Osdi HER-2/NEU Elisa)NCW · Traditional 09/29/2000SE
K002121Total Psa Microtiter ElisaLTJ · Traditional 08/30/2000SE

Questions and answers

When was Complexed Psa Microtiter Elisa cleared by the FDA?

Complexed Psa Microtiter Elisa (K002313) received a 510(k) decision of Substantially Equivalent on August 30, 2000, 30 days after the submission was received.

What is the product code of K002313?

The FDA product code is LTJ – Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, a Class II (moderate risk) device regulated under 21 CFR 866.6010.