K950308 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA. This device is classified as a Block, Cutting, Ent, Sterile (Class I - General Controls, product code JXS).
Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 14, 1995, 79 days after receiving the submission on January 25, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 874.3540.
| 510(k) Number | K950308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1995 |
| Decision Date | April 14, 1995 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | JXS — Block, Cutting, Ent, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.3540 |