Submission Details
| 510(k) Number | K926253 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 14, 1992 |
| Decision Date | July 14, 1995 |
| Days to Decision | 942 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
Cleared
Traditional
SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE
Jul 1995
Decision
942d
Days
Class 2
Risk
About This 510(k) Submission
K926253 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sudormed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 14, 1995, 942 days after receiving the submission on December 14, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1675.
Device Classification
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
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