Opus Immunoassay System
FDA 510(k) K894159 · Pb Diagnostic Systems, Inc.
510(k) numberK894159
Submission
- Device name
- Opus Immunoassay System
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- June 14, 1989
- Decision date
- August 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K952719 | Biocircuits Ios (In-Office System)KHO · Traditional | Biocircuits Corp. | 11/22/1995SE |
| 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 |
More from Tosoh Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K940507 | Opus FT4 Test SystemCEC · Traditional | 07/28/1994SE |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | 07/20/1994SE |
| K933389 | Opus Cmv-GLFZ · Traditional | 06/28/1994SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | 03/07/1994SE |
| K935229 | Opus DigitoxinDPG · Traditional | 12/22/1993SE |
| K934705 | Opus NapaLAN · Traditional | 11/22/1993SE |
| K933675 | Opus Total CKCGS · Traditional | 09/08/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | 09/08/1993SE |
| K932279 | Opus(R) Total B-Hcg Test SystemJHI · Traditional | 07/08/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | 06/07/1993SE |
Questions and answers
When was Opus Immunoassay System cleared by the FDA?
Opus Immunoassay System (K894159) received a 510(k) decision of Substantially Equivalent on August 3, 1989, 50 days after the submission was received.
What is the product code of K894159?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.