STC Diagnostics LSD Micro-Plate Eia
FDA 510(k) K954073 · Solarcare Technologies Corp,Inc.
510(k) numberK954073
Submission
- Device name
- STC Diagnostics LSD Micro-Plate Eia
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- August 30, 1995
- Decision date
- November 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DLB – Radioimmunoassay, Lsd (125-I)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3580
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DLB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961436 | Abuscreen Online LSD Reagent (90 ML Test Kit)DLB · Traditional | Roche Diagnostic Systems, Inc. | 06/21/1996SE |
| K955448 | Emit II LSD Assay, Emit LSD Calibrators & Emit LSD ControlsDLB · Traditional | Behring Diagnostics, Inc. | 02/23/1996SE |
| K955814 | Cedia Dau LSD AssayDLB · Traditional | Microgenics Corp. | 02/09/1996SE |
| K891167 | Coat-A-Count(Tm) LSD Radioimmunoassay KitDLB · Traditional | Diagnostic Products Corp. | 05/03/1989SE |
| K874270 | Revised Labeling for LSD Test KitDLB · Traditional | Roche Diagnostic Systems, Inc. | 11/13/1987SE |
| K860525 | Abuscreen Radioimmunoassay for LSD W/ Ref StandardDLB · Traditional | Roche Diagnostic Systems, Inc. | 04/11/1986SE |
More from Roche Diagnostic Systems, 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 |
| 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 LSD Micro-Plate Eia cleared by the FDA?
STC Diagnostics LSD Micro-Plate Eia (K954073) received a 510(k) decision of Substantially Equivalent on November 29, 1995, 91 days after the submission was received.
What is the product code of K954073?
The FDA product code is DLB – Radioimmunoassay, Lsd (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3580.