STC Diagnostics Auto-Lyte PH Assay
FDA 510(k) K954158 · Solarcare Technologies Corp,Inc.
510(k) numberK954158
Submission
- Device name
- STC Diagnostics Auto-Lyte PH Assay
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- September 5, 1995
- Decision date
- April 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KQO – Automated Urinalysis System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2900
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141874 | Uriscan OptimaKQO · Traditional | Yd Diagnostics Corp. | 05/28/2015SE |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…KQO · Traditional | ACON Laboratories, Inc. | 05/11/2015SE |
| K140717 | Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration…KQO · Traditional | Siemens Healthcare Diagnostics | 11/17/2014SE |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | Arkray, Inc. | 02/01/2013SE |
| K102188 | Cybow Reader, Models 300 & 720KQO · Traditional | DFI Co., Ltd. | 08/09/2011SE |
| K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitKQO · Traditional | Iris International Inc., A Division of Iris Iris I | 03/23/2011SE |
| K091472 | Uritest 50 and Uritest 500 Urine AnalyzerKQO · Traditional | Arj Medical, Inc. | 04/27/2010SE |
| K093555 | Cobas U411 Test SystemKQO · Traditional | Roche Diagnostics | 04/02/2010SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | Arkray, Inc. | 12/23/2009SE |
| K070929 | Acon U120 Urine Analyzer, Model U111-101KQO · Traditional | ACON Laboratories, Inc. | 07/30/2007SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954326 | STC Diagnostics Auto-Lyte Urinary Hemoglobin AssayJIT · Traditional | 07/23/1996SE |
| K954156 | STC Diagnostics Auto-Lyte Urinary Leukocyte Esterase AssayKQO · Traditional | 07/22/1996SE |
| K955905 | STC Diagnostics Auto-Lyte Urinary Protein AssayCEK · Traditional | 05/30/1996SE |
| K940048 | STC Diagnostics PCP Micro-Plate Eia ModificationDLJ · Traditional | 03/19/1996SE |
| K954073 | STC Diagnostics LSD Micro-Plate EiaDLB · Traditional | 11/29/1995SE |
| K954266 | STC Diagnostics Auto-Lyte Creatinine AssayCGX · Traditional | 10/13/1995SE |
| K935573 | Amphetamines Micro-Plate EiaDKZ · Traditional | 07/14/1995SE |
| K935565 | Opiates Micro-Plate AssayDJG · Traditional | 07/14/1995SE |
| K950308 | STC Diagnostics Auto-Lyte(R) Methaqualone EiaJXS · Traditional | 04/14/1995SE |
| K944056 | Auto-Lyte Methadone DiaDJR · Traditional | 12/29/1994SE |
Questions and answers
When was STC Diagnostics Auto-Lyte PH Assay cleared by the FDA?
STC Diagnostics Auto-Lyte PH Assay (K954158) received a 510(k) decision of Substantially Equivalent on April 30, 1996, 238 days after the submission was received.
What is the product code of K954158?
The FDA product code is KQO – Automated Urinalysis System, a Class I (low risk) device regulated under 21 CFR 862.2900.