STC Diagnostics Auto-Lyte Cannabinoids Eia
FDA 510(k) K930654 · Solarcare Technologies Corp,Inc.
510(k) numberK930654
Submission
- Device name
- STC Diagnostics Auto-Lyte Cannabinoids Eia
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- February 9, 1993
- Decision date
- May 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
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| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
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More from Healgen Scientific,, LLC
| 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 Cannabinoids Eia cleared by the FDA?
STC Diagnostics Auto-Lyte Cannabinoids Eia (K930654) received a 510(k) decision of Substantially Equivalent on May 6, 1993, 86 days after the submission was received.
What is the product code of K930654?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.