The Robolite
FDA 510(k) K964460 · Shai Syg Motion and Innovations, Ltd.
510(k) numberK964460
Submission
- Device name
- The Robolite
- Applicant
- Shai Syg Motion and Innovations, Ltd.
Efrat, IL - Received
- November 7, 1996
- Decision date
- January 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K871853 | V-Marc 88A ComputerJQP · Traditional | V.Marc, A Div. of Pictorial, Inc. | 07/16/1987SE |
More from V.Marc, A Div. of Pictorial, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961849 | The RoboguideIZH · Traditional | 08/21/1996SE |
Questions and answers
When was The Robolite cleared by the FDA?
The Robolite (K964460) received a 510(k) decision of Substantially Equivalent on January 24, 1997, 78 days after the submission was received.
What is the product code of K964460?
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.