Reporting Integrator 3392A
FDA 510(k) K833113 · Hewlett-Packard Co.
510(k) numberK833113
Submission
- Device name
- Reporting Integrator 3392A
- Applicant
- Hewlett-Packard Co.
Walker, MI, US - Received
- September 13, 1983
- Decision date
- November 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K942451 | Bio-Rad Clinical Data Management SystemLDM · Traditional | Bio-Rad | 11/10/1994SE |
| 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 |
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| K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…MHX · Abbreviated | 01/28/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | 01/20/2000SE |
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| K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-St Segment Measurement…MHX · Special | 12/08/1999SE |
| K992977 | Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AMKJ · Traditional | 12/01/1999SE |
| K993516 | HP M2600A Viridia Telemetry SystemDSI · Special | 11/08/1999SE |
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| K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special | 10/21/1999SE |
Questions and answers
When was Reporting Integrator 3392A cleared by the FDA?
Reporting Integrator 3392A (K833113) received a 510(k) decision of Substantially Equivalent on November 21, 1983, 69 days after the submission was received.
What is the product code of K833113?
The FDA product code is LDM – Instrumentation, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.