Product code LTJ— Immunology
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
- Classification name
- Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Total cleared
- 34
- First cleared
- Most recent
Market context for product code LTJ
FDA has cleared devices under product code LTJ between 1997 and 2026, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2017
- 2013
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
Top applicants under product code LTJ
Recent clearances under product code LTJ
- K251630 — Atellica IM Total PSA II (tPSAII)
- K162378 — FREND PSA PLUS (reagent cartridge)
- K124056 — FREND PSA PLUS (REAGENT CARTRIDGE)
- K031343 — TPSA FLEX REAGENT CARTRIDGE
- K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
- K010550 — VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
- K003963 — DIMENSION PSA FLEX REAGENT CARTRIDGE
- K002376 — ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
- K003094 — FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
- K002121 — TOTAL PSA MICROTITER ELISA
- K002313 — COMPLEXED PSA MICROTITER ELISA
- K994419 — FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
- K994221 — BAYER PSA ASSAY
- K000566 — MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
- K990234 — QUALISYS PSA IMMUNOASSAY
- K984289 — VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
- K982948 — ELECSYS PSA, MODEL # ELECSYS 1010
- K982949 — ELECSYS PSA, MODEL 2010
- K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
- K981839 — ACS:CENTAUR PSA2 IMMUNOASSAY
- K973243 — ACTIVE PSA ELISA (DSL-10-9700)
- K973244 — ACTIVE PSA IRMA (DSL-9700)
- K980376 — THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K974842 — IMMULITE 2000 3RD GENERATION PSA
- K980716 — ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
- K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
- K974189 — ELECSYS PSA (ON ELECSYS 1010)
- K972021 — IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
- K973101 — PROSTATE SPECIFIC ANTIGEN METHOD
- K972095 — IMMULITE 2000 PSA
- K964351 — ELECSYS PSA ASSAY
- K964595 — OPUS PSA TEST SYSTEM
- K965085 — ENZYMUN-TEST PSA
Data sourced from openFDA. This site is unofficial and independent of the FDA.