Biocircuits Ios (In-Office System)
FDA 510(k) K952719 · Biocircuits Corp.
510(k) numberK952719
Submission
- Device name
- Biocircuits Ios (In-Office System)
- Applicant
- Biocircuits Corp.
Sunnyvale, CA, US - Received
- June 15, 1995
- Decision date
- November 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112161 | AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…KHO · Traditional | Radiometer Medical Aps | 01/20/2012SE |
| K973547 | Triage StatmeterKHO · Traditional | Biosite Incorporated | 01/13/1998SE |
| K971103 | Aia Nexia-Automated Enzyme Immunoassay SystemKHO · Traditional | Tosoh Medics, Inc. | 06/27/1997SE |
| K962919 | Vitros Immunodiagnostic SystemKHO · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 10/18/1996SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | Isolab, Inc. | 09/05/1995SE |
| K935047 | Auto DelfiaKHO · Traditional | Wallac OY | 05/23/1994SE |
| K930689 | Autobead Thyroid UptakeKHO · Traditional | Bio-Chem Laboratory Systems, Inc. | 11/10/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | Pb Diagnostic Systems, Inc. | 06/07/1993SE |
| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | Tosoh Corp. | 07/21/1992SE |
| K920888 | Microlite Microtiter Plate Luminometer ML2200KHO · Traditional | Dynatech Laboratories, Inc. | 03/19/1992SE |
More from Dynatech Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981634 | Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa…LTJ · Traditional | 10/13/1998SE |
| 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 |
| 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 (In-Office System) cleared by the FDA?
Biocircuits Ios (In-Office System) (K952719) received a 510(k) decision of Substantially Equivalent on November 22, 1995, 160 days after the submission was received.
What is the product code of K952719?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.