Assay Software for DPC-MARJ5 Alastat Eia Software
FDA 510(k) K923879 · Diagnostic Products Corp.
510(k) numberK923879
Submission
- Device name
- Assay Software for DPC-MARJ5 Alastat Eia Software
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- August 3, 1992
- Decision date
- December 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2750
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQW
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|---|---|---|---|
| K023955 | BD Viper InstrumentJQW · Traditional | Becton, Dickinson & CO | 06/24/2003SE |
| K973335 | Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional | Zenyx Scientific , Ltd. | 04/30/1998SE |
| K980180 | 2700 Sample ManagerJQW · Traditional | Waters Corporation | 02/12/1998SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | Pharmacia, Inc. | 06/30/1997SE |
| K970616 | Mini Sampler ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 04/21/1997SE |
| K962687 | Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional | Nichols Institute Diagnostics | 03/28/1997SE |
| K962859 | Mini Sample ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 10/29/1996SE |
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | Hamilton Co. | 08/16/1996SE |
| K961694 | ImpactJQW · Traditional | Matrix Technologies Corp. | 06/21/1996SE |
| K953345 | GenesisJQW · Traditional | Tecan U.S., Inc. | 11/21/1995SE |
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Questions and answers
When was Assay Software for DPC-MARJ5 Alastat Eia Software cleared by the FDA?
Assay Software for DPC-MARJ5 Alastat Eia Software (K923879) received a 510(k) decision of Substantially Equivalent on December 7, 1992, 126 days after the submission was received.
What is the product code of K923879?
The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.