MR7000 with Time Manager Software (TMS)
FDA 510(k) K934111 · Dynatech Laboratories, Inc.
510(k) numberK934111
Submission
- Device name
- MR7000 with Time Manager Software (TMS)
- Applicant
- Dynatech Laboratories, Inc.
Chantilly, VA, US - Received
- August 3, 1993
- Decision date
- November 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K964460 | The RoboliteJQP · Traditional | Shai Syg Motion and Innovations, Ltd. | 01/24/1997SE |
| K953652 | Prenval IJQP · Traditional | Base Ten Systems, Inc. | 09/15/1995SE |
| 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 |
|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | 07/25/1996SE |
| K943701 | MRX Microplate ReaderJJQ · Traditional | 10/20/1994SE |
| K923456 | Microlite Microtiter Plate Luminometer ML3000JJQ · Traditional | 10/13/1992SE |
| K915896 | Microlite Microtiter Plate Luminometer ML2250/MODIJJQ · Traditional | 05/04/1992SE |
| K920888 | Microlite Microtiter Plate Luminometer ML2200KHO · Traditional | 03/19/1992SE |
| K913590 | Microlite ML 1000 Microtiter Plate LuminometerJJQ · Traditional | 10/25/1991SE |
| K895313 | Microlite ML 1000 (Model 3) Microplate LuminometerJJQ · Traditional | 10/17/1989SE |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | 10/17/1989SE |
| K894687 | Dynatech MR 5000, Catalog #011-976-0600JJQ · Traditional | 08/31/1989SE |
| K890502 | Microlite Tube Luminometer #011-902-0000JJQ · Traditional | 02/27/1989SE |
Questions and answers
When was MR7000 with Time Manager Software (TMS) cleared by the FDA?
MR7000 with Time Manager Software (TMS) (K934111) received a 510(k) decision of Substantially Equivalent on November 2, 1994, 456 days after the submission was received.
What is the product code of K934111?
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.