510(k) K936135
K936135 is an FDA 510(k) premarket notification submitted by Sudormed, Inc. for the device "SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION". The FDA issued a decision of Substantially Equivalent on June 10, 1996. The device falls under product code LAT (Radioimmunoassay, Cannabinoid(S)), a Class II device regulated under 21 CFR 862.3870. Sudormed, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1996
- Date Received
- December 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Cannabinoid(S)
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type