SP 120 Sophisticate
FDA 510(k) K802251 · Vickers America Medical Corp.
510(k) numberK802251
Submission
- Device name
- SP 120 Sophisticate
- Applicant
- Vickers America Medical Corp.
Walker, MI, US - Received
- September 16, 1980
- Decision date
- October 23, 1980
- 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 |
|---|---|---|
| K840823 | Treonic C30LDR · Traditional | 03/23/1984SE |
| K831838 | Laboratory Data MGMT System SDMSJQP · Traditional | 01/24/1984SE |
| K830748 | ResuscitaireFMT · Traditional | 06/22/1983SE |
| K830936 | Treonic IP5FRN · Traditional | 04/12/1983SE |
| K813239 | Oxygenaire Nuring IncubatorFMZ · Traditional | 01/28/1982SE |
| K813238 | Neocare Baby-Controlled IncubatorFMZ · Traditional | 01/22/1982SE |
| K811865 | Vma Pediatric Apnea MattressBZQ · Traditional | 07/31/1981SE |
| K810792 | Neocare Temperature MonitorFMZ · Traditional | 04/29/1981SE |
| K810571 | Neocare Oxygen MonitorCCL · Traditional | 03/11/1981SE |
| K810067 | 140 Neocare Air Controlled IncubatorFMZ · Traditional | 03/11/1981SE |
Questions and answers
When was SP 120 Sophisticate cleared by the FDA?
SP 120 Sophisticate (K802251) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 37 days after the submission was received.
What is the product code of K802251?
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.