Modofication to Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic Products Psa Calibrators
FDA 510(k) K000566 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK000566
Submission
- Device name
- Modofication to Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic Products Psa Calibrators
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- February 22, 2000
- Decision date
- March 9, 2000
- 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 |
| 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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Questions and answers
When was Modofication to Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic Products Psa Calibrators cleared by the FDA?
Modofication to Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic Products Psa Calibrators (K000566) received a 510(k) decision of Substantially Equivalent on March 9, 2000, 16 days after the submission was received.
What is the product code of K000566?
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.