LTJ — Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Class II
FDA product code LTJ covers "Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LTJ
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251630 | siemens healthcare diagnostics | Atellica IM Total PSA II (tPSAII) | January 5, 2026 |
| K162378 | nanoentek usa | FREND PSA PLUS (reagent cartridge) | May 17, 2017 |
| K124056 | nanoentek | FREND PSA PLUS (REAGENT CARTRIDGE) | May 29, 2013 |
| K031343 | dade behring | TPSA FLEX REAGENT CARTRIDGE | May 15, 2003 |
| K022288 | bayer | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED | December 17, 2002 |
| K022177 | bayer diagnostics | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | December 17, 2002 |
| K010550 | biomerieux | VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 | April 24, 2001 |
| K003963 | dade behring | DIMENSION PSA FLEX REAGENT CARTRIDGE | February 28, 2001 |
| K002376 | bayer | ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY | October 26, 2000 |
| K003094 | qualigen | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | October 25, 2000 |
| K002313 | oncogene science | COMPLEXED PSA MICROTITER ELISA | August 30, 2000 |
| K002121 | oncogene science | TOTAL PSA MICROTITER ELISA | August 30, 2000 |
| K994419 | qualisys diagnostics | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM | June 28, 2000 |
| K994221 | bayer | BAYER PSA ASSAY | April 13, 2000 |
| K000566 | ortho-clinical diagnostics | MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODI | March 9, 2000 |
| K990234 | qualisys diagnostics | QUALISYS PSA IMMUNOASSAY | July 8, 1999 |
| K984289 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUC | March 12, 1999 |
| K982948 | boehringer mannheim | ELECSYS PSA, MODEL # ELECSYS 1010 | October 27, 1998 |
| K982949 | boehringer mannheim | ELECSYS PSA, MODEL 2010 | October 27, 1998 |
| K981634 | biocircuits | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS | October 13, 1998 |