Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls
FDA 510(k) K981634 · Biocircuits Corp.
510(k) numberK981634
Submission
- Device name
- Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls
- Applicant
- Biocircuits Corp.
Sunnyvale, CA, US - Received
- May 8, 1998
- Decision date
- October 13, 1998
- 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 |
More from Qualigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980819 | Biocircuits Ios Free Thyroxine (FT4) Test Cartridges Biocircuits Ios ControlsCEC · Traditional | 04/03/1998SE |
| K963770 | Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay ControlsJJY · Traditional | 12/05/1996SE |
| K961566 | Biocircuits Ios TSH Test Cartridges/Thyroid ControlsJLW · Traditional | 11/18/1996SE |
| K961792 | Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay ControlsDHA · Traditional | 08/21/1996SE |
| K952719 | Biocircuits Ios (In-Office System)KHO · Traditional | 11/22/1995SE |
| K953837 | Biocircuits Ios T4 Test CartridgeKLI · Traditional | 11/20/1995SE |
| K952751 | Biocircuits Ios T4/TU Test CartridgesKLI · Traditional | 11/20/1995SE |
Questions and answers
When was Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls cleared by the FDA?
Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls (K981634) received a 510(k) decision of Substantially Equivalent on October 13, 1998, 158 days after the submission was received.
What is the product code of K981634?
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.