510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936135Substantially Equivalent

Sudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration

Sudormed, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936135 is the FDA 510(k) clearance record for SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION, a class II device, cleared for Sudormed, Inc. on under FDA product code LAT (Radioimmunoassay, Cannabinoid(S)). FDA records list 6 510(k) clearances for Sudormed, Inc., from to . As of , FDA records show no recalls naming K936135.

Clearance record

Decision date
Received
(895 days to decision)
Product code
LAT Radioimmunoassay, Cannabinoid(S)
Regulation
21 CFR 862.3870
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Sudormed, Inc. 12341 Newport Ave., #D-200, Santa Ana CA
510(k) summary
Statement
Third party review
No

Clearances, product code LAT

Trailing 12 months

FDA records hold no clearances under product code LAT in the trailing twelve months.

FDA records show no clearances under product code LAT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LAT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260