The following data is part of a premarket notification filed by Sudormed, Inc. with the FDA for Sudormed Sweat Patch Specimen Container.
| Device ID | K902442 |
| 510k Number | K902442 |
| Device Name: | SUDORMED SWEAT PATCH SPECIMEN CONTAINER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SUDORMED, INC. 24121 BIG TIMBER Lake Forest, CA 92630 |
| Contact | Booher, Ph.d. |
| Correspondent | Booher, Ph.d. SUDORMED, INC. 24121 BIG TIMBER Lake Forest, CA 92630 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-01 |
| Decision Date | 1990-10-04 |