Fluorometer, General Use
FDA 510(k) K830624 · Abbott Diagnostics
510(k) numberK830624
Submission
- Device name
- Fluorometer, General Use
- Applicant
- Abbott Diagnostics
Mountain View, CA, US - Received
- February 28, 1983
- Decision date
- April 5, 1983
- 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 |
|---|---|---|
| K964185 | Imx Ca 125LTK · Traditional | 11/04/1997SE |
| K972182 | Abbott Strep a ControlsMJZ · Traditional | 08/13/1997SE |
| K961439 | Abbott Cell-Dyn 4000 SystemGKZ · Traditional | 10/18/1996SE |
| K890491 | Cell-Dyn 3000 Multi-Parameter Hematology AnalyerGKZ · Traditional | 04/18/1989SE |
| K881242 | Cell-Dyn Rapid-Lyse and HemogloblinGJZ · Traditional | 04/21/1988SE |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | 03/31/1988SE |
| K873348 | Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional | 09/09/1987SE |
| K873347 | Cell-Dyn Diff. Screen Isotonic DiluentGIF · Traditional | 09/09/1987SE |
| K873408 | Model 690 SpectrophotometerJJQ · Traditional | 09/08/1987SE |
| K872761 | Cell-Dyn 610 Hematology AnalyzerGKZ · Traditional | 08/06/1987SE |
Questions and answers
When was Fluorometer, General Use cleared by the FDA?
Fluorometer, General Use (K830624) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 36 days after the submission was received.
What is the product code of K830624?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.