Lyris Modular Info System
FDA 510(k) K831830 · Biovation, Inc.
510(k) numberK831830
Submission
- Device name
- Lyris Modular Info System
- Applicant
- Biovation, Inc.
Walker, MI, US - Received
- June 7, 1983
- Decision date
- June 25, 1984
- 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
Other 510(k)s with product code JQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113007 | Bionime Diabetes Management System VI.0JQP · Traditional | Bionime Corporation | 02/27/2012SE |
| 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 |
More from Quantitative Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925528 | Biovation K-ManagerGKZ · Traditional | 02/05/1993SE |
| K923844 | Lyris 100/120 Laboratory Information SystemJJQ · Traditional | 12/11/1992SE |
| K915071 | Differential Counting BoardGKZ · Traditional | 01/17/1992SE |
| K853026 | Biovation Max Data Management SystemJQP · Traditional | 08/02/1985SE |
| K842401 | Chemistry ConsoleJQP · Traditional | 09/04/1984SE |
| K821534 | Hematology Data Management SysJGP · Traditional | 06/10/1982SE |
| K812604 | Biovation Urinalysis ReporterJQP · Traditional | 10/02/1981SE |
| K792045 | Biovation NephelometerJQX · Traditional | 10/30/1979SE |
| K790862 | Biovation Digital UrinometerJRE · Traditional | 06/28/1979SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | 10/03/1978SE |
Questions and answers
When was Lyris Modular Info System cleared by the FDA?
Lyris Modular Info System (K831830) received a 510(k) decision of Substantially Equivalent on June 25, 1984, 384 days after the submission was received.
What is the product code of K831830?
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.