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 |