STC Diagnostics Auto-Lyte(Tm) Ethyl Alcohol Assay
FDA 510(k) K931516 · Solarcare Technologies Corp,Inc.
510(k) numberK931516
Submission
- Device name
- STC Diagnostics Auto-Lyte(Tm) Ethyl Alcohol Assay
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- March 26, 1993
- Decision date
- July 19, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
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More from Dade Behring, 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 |
| 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 Auto-Lyte(Tm) Ethyl Alcohol Assay cleared by the FDA?
STC Diagnostics Auto-Lyte(Tm) Ethyl Alcohol Assay (K931516) received a 510(k) decision of Substantially Equivalent on July 19, 1993, 115 days after the submission was received.
What is the product code of K931516?
The FDA product code is DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.