The following data is part of a premarket notification filed by Somas Medical Industries, Inc. with the FDA for Somas Liquid Urine Control.
| Device ID | K862179 |
| 510k Number | K862179 |
| Device Name: | SOMAS LIQUID URINE CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SOMAS MEDICAL INDUSTRIES, INC. 2740 S. HARBOR BLVD. SUITE F Santa Ana, CA 92704 -5824 |
| Contact | Som, Ph.d. |
| Correspondent | Som, Ph.d. SOMAS MEDICAL INDUSTRIES, INC. 2740 S. HARBOR BLVD. SUITE F Santa Ana, CA 92704 -5824 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-07-01 |