510(k) K862179
K862179 is an FDA 510(k) premarket notification submitted by Somas Medical Industries, Inc. for the device "SOMAS LIQUID URINE CONTROL". The FDA issued a decision of Substantially Equivalent on July 1, 1986. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Somas Medical Industries, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1986
- Date Received
- June 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multi-Analyte Controls, All Kinds (Assayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type