Submission Details
| 510(k) Number | K936240 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 30, 1993 |
| Decision Date | March 19, 1996 |
| Days to Decision | 810 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
Cleared
Traditional
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
Mar 1996
Decision
810d
Days
Class 2
Risk
About This 510(k) Submission
K936240 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE), 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 March 19, 1996, 810 days after receiving the submission on December 30, 1993. 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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