Bio-Rad Clinical Data Management System
FDA 510(k) K942451 · Bio-Rad
510(k) numberK942451
Submission
- Device name
- Bio-Rad Clinical Data Management System
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- May 23, 1994
- Decision date
- November 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDM – Instrumentation, High Pressure Liquid Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LDM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960392 | CDMLDM · Traditional | Bio-Rad | 07/08/1996SE |
| K961557 | Alliance 2690 Separations ModuleLDM · Traditional | Waters Corporation | 07/05/1996SE |
| K922388 | Waters(Tm) LC Module I for Clinical UseLDM · Traditional | Millipore Corp. | 09/11/1992SE |
| K920136 | Waters 717 AutosamplerLDM · Traditional | Millipore Corp. | 02/19/1992SE |
| K903647 | Module 486 Variable Wavelength Tunable Uv/Vis DeteLDM · Traditional | Millipore Corp. | 09/11/1990SE |
| K884886 | Model 250 Liquid Chromotagraphy PumpLDM · Traditional | The Perkin-Elmer Corp. | 02/02/1989SE |
| K872582 | High Pressure Liquid Chromatography SystemLDM · Traditional | Millipore Corp. | 07/16/1987SE |
| K870949 | Waters 650 Advanced Protein Purification SystemLDM · Traditional | Millipore Corp. | 04/22/1987SE |
| K862178 | Isopure LC SystemLDM · Traditional | The Perkin-Elmer Corp. | 07/14/1986SE |
| K850272 | Waters 740 Data Module-Plotter IntegratorLDM · Traditional | Millipore Corp. | 03/06/1985SE |
More from Millipore Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Bio-Rad Clinical Data Management System cleared by the FDA?
Bio-Rad Clinical Data Management System (K942451) received a 510(k) decision of Substantially Equivalent on November 10, 1994, 171 days after the submission was received.
What is the product code of K942451?
The FDA product code is LDM – Instrumentation, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.