STC Diagnostics AUTO0LYTE Cocaine Metabolite Eia
FDA 510(k) K921140 · Solarcare Technologies Corp,Inc.
510(k) numberK921140
Submission
- Device name
- STC Diagnostics AUTO0LYTE Cocaine Metabolite Eia
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- March 10, 1992
- Decision date
- August 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JXO – Enzyme Immunoassay, Cocaine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairJXO · Traditional | Psychemedics Corporation | 06/25/2021SE |
| K111925 | Psychemedics Cocaine EiaJXO · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K923314 | Automates Coma Plus Cocaine Metabolite AssayJXO · Traditional | Serex, Inc. | 08/24/1992SE |
| K915785 | STC Diagnostics Benzoylecgonine EiaJXO · Traditional | Solarcare Technologies Corp,Inc. | 03/11/1992SE |
| K913737 | Il Test(Tm) CocaineJXO · Traditional | Instrumentation Laboratory CO | 12/03/1991SE |
More from Instrumentation Laboratory CO
| 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 |
| K954158 | STC Diagnostics Auto-Lyte PH AssayKQO · Traditional | 04/30/1996SE |
| 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 |
Questions and answers
When was STC Diagnostics AUTO0LYTE Cocaine Metabolite Eia cleared by the FDA?
STC Diagnostics AUTO0LYTE Cocaine Metabolite Eia (K921140) received a 510(k) decision of Substantially Equivalent on August 20, 1992, 163 days after the submission was received.
What is the product code of K921140?
The FDA product code is JXO – Enzyme Immunoassay, Cocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3250.