STC Diagnostics Auto-Lyte(R) Methaqualone Eia
FDA 510(k) K950308 · Solarcare Technologies Corp,Inc.
510(k) numberK950308
Submission
- Device name
- STC Diagnostics Auto-Lyte(R) Methaqualone Eia
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- January 25, 1995
- Decision date
- April 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JXS – Block, Cutting, Ent, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3540
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code JXS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K822371 | Micro WorktableJXS · Traditional | Treace Medical, Inc. | 09/09/1982SE |
More from Treace Medical, 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 |
| K944056 | Auto-Lyte Methadone DiaDJR · Traditional | 12/29/1994SE |
Questions and answers
When was STC Diagnostics Auto-Lyte(R) Methaqualone Eia cleared by the FDA?
STC Diagnostics Auto-Lyte(R) Methaqualone Eia (K950308) received a 510(k) decision of Substantially Equivalent on April 14, 1995, 79 days after the submission was received.
What is the product code of K950308?
The FDA product code is JXS – Block, Cutting, Ent, Sterile, a Class I (low risk) device regulated under 21 CFR 874.3540.