Enzymun-Test Psa
FDA 510(k) K965085 · Boehringer Mannheim Corp.
510(k) numberK965085
Submission
- Device name
- Enzymun-Test Psa
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- December 19, 1996
- Decision date
- March 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K031343 | Tpsa Flex Reagent CartridgeLTJ · Special | Dade Behring, Inc. | 05/15/2003SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Enzymun-Test Psa cleared by the FDA?
Enzymun-Test Psa (K965085) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 90 days after the submission was received.
What is the product code of K965085?
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.