Submission Details
| 510(k) Number | K902442 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 1990 |
| Decision Date | October 04, 1990 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
SUDORMED SWEAT PATCH SPECIMEN CONTAINER
Oct 1990
Decision
125d
Days
Class 2
Risk
About This 510(k) Submission
K902442 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sudormed, Inc. (Lake Forest, US). The FDA issued a Cleared decision on October 4, 1990, 125 days after receiving the submission on June 1, 1990. This device falls under the Chemistry 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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