Data Reduction System, DP-3000
FDA 510(k) K770877 · Beckman Instruments, Inc.
510(k) numberK770877
Submission
- Device name
- Data Reduction System, DP-3000
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- May 16, 1977
- Decision date
- July 21, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2100
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K983468 | Fasttake Adapter, Model # P/N 020-072-01JQP · Traditional | Selfcare, Inc. | 12/17/1998SE |
| K964460 | The RoboliteJQP · Traditional | Shai Syg Motion and Innovations, Ltd. | 01/24/1997SE |
| K953652 | Prenval IJQP · Traditional | Base Ten Systems, Inc. | 09/15/1995SE |
| K934111 | MR7000 with Time Manager Software (TMS)JQP · Traditional | Dynatech Laboratories, Inc. | 11/02/1994SE |
| K923316 | Expresso CartridgeJQP · Traditional | Bio-Rad Laboratories, Inc. | 02/23/1993SE |
| K893838 | Modified Model 570 Clinical Chemistry AnalyzerJQP · Traditional | Ciba Corning Diagnostics Corp. | 08/31/1989SE |
| K892060 | Cyberlab High Volume Drug Testing SystemJQP · Traditional | Syva Co. | 08/10/1989SE |
| K885292 | Cobas MFCJQP · Traditional | Roche Diagnostic Systems, Inc. | 03/22/1989SE |
| K881194 | Ria-QuickJQP · Traditional | Quantitative Technologies, Inc. | 06/01/1988SE |
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Questions and answers
When was Data Reduction System, DP-3000 cleared by the FDA?
Data Reduction System, DP-3000 (K770877) received a 510(k) decision of Substantially Equivalent on July 21, 1977, 66 days after the submission was received.
What is the product code of K770877?
The FDA product code is JQP – Calculator/Data Processing Module, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2100.