Tpsa Flex Reagent Cartridge
FDA 510(k) K031343 · Dade Behring, Inc.
510(k) numberK031343
Submission
- Device name
- Tpsa Flex Reagent Cartridge
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- April 29, 2003
- Decision date
- May 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/05/2026SE |
| K162378 | FREND PSA PLUS (reagent cartridge)LTJ · Traditional | Nanoentek USA, Inc. | 05/17/2017SE |
| K124056 | Frend Psa Plus (Reagent Cartridge)LTJ · Traditional | Nanoentek, Inc. | 05/29/2013SE |
| K022288 | Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module…LTJ · Traditional | Bayer Corp. | 12/17/2002SE |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | Bayer Diagnostics Corp. | 12/17/2002SE |
| K010550 | Vidas Total Prostate Specific Antigen (Tpsa), Model 30 428LTJ · Traditional | bioMerieux, Inc. | 04/24/2001SE |
| K003963 | Dimension Psa Flex Reagent CartridgeLTJ · Traditional | Dade Behring, Inc. | 02/28/2001SE |
| K002376 | Advia: Centaur and Acs: 180 Cpsa AssayLTJ · Traditional | Bayer Corp. | 10/26/2000SE |
| K003094 | Fastpack Psa Immunoassay, Fastpack AnalyzerLTJ · Special | Qualigen, Inc. | 10/25/2000SE |
| K002313 | Complexed Psa Microtiter ElisaLTJ · Traditional | Oncogene Science, Inc. | 08/30/2000SE |
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| 510(k) | Device | Decision |
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| K093848 | Pt-Multi-Calibrator, Model OPAT07GGN · Traditional | 12/20/2010SE |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional | 07/28/2008SE |
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | 07/21/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | 06/25/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | 03/13/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | 02/26/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | 02/21/2008SE |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
Questions and answers
When was Tpsa Flex Reagent Cartridge cleared by the FDA?
Tpsa Flex Reagent Cartridge (K031343) received a 510(k) decision of Substantially Equivalent on May 15, 2003, 16 days after the submission was received.
What is the product code of K031343?
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.