Panels › Immunology › Product code LTJ · Class 2
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Regulation 866.6010
1510(k)s in 12 months (34 all time)
1recalls in 12 months (12 all time)
2recalls that name a 510(k)
Top companies in LTJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Boehringer Mannheim Corp. | 5 | 0 |
| Bayer Corp. | 4 | 0 |
| Dade Behring, Inc. | 2 | 1 |
| Diagnostic Products Corp. | 3 | 0 |
| Qualigen, Inc. | 1 | 2 |
| BioCheck Inc | 0 | 2 |
| Diagnostic Systems Laboratories, Inc. | 2 | 0 |
| Nanoentek USA, Inc. | 2 | 0 |
| Oncogene Science, Inc. | 2 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB PSA Test Open, Classified |
LTJ | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK PA; Part Number: 025263
Assay, Tumor Marker Terminated |
LTJ | None listed |
| Aug 9, 2016 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test) Terminated |
LTJ | None listed |
| Dec 19, 2013 | Qualigen Inc FastPack Total PSA Immunoassay
Chemilunescence assay for the determination of Total PSA.
FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determina Terminated |
LTJ | K994419 |
| Mar 11, 2011 | BioCheck Inc Free PSA ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LTJ | None listed |
| Mar 11, 2011 | BioCheck Inc PSA ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LTJ | None listed |
| Apr 28, 2009 | Beckman Coulter Inc Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205.
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitativ Terminated |
LTJ | None listed |
| Dec 22, 2008 | Qualigen Inc FastPack(R) Total PSA Immunoassay; Catalog #: 25000001
Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma Terminated |
LTJ | K994419 |
| Sep 16, 2008 | Siemens Medical Solutions Diagnostics COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy. Terminated |
LTJ | None listed |
| Jan 11, 2006 | Roche Diagnostics Corp. Roche Elecsys total PSA CalSet, catalog number 11731696322. Terminated |
LTJ | None listed |
| Jan 11, 2006 | Roche Diagnostics Corp. Roche Elecsys total PSA, catalog number 11731262322. Terminated |
LTJ | None listed |
| May 29, 2003 | Dade Behring Inc Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton. Terminated |
LTJ | None listed |
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