510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792429Substantially Equivalent

Him Test Cocaine

Tecknam, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792429 is the FDA 510(k) clearance record for HIM TEST COCAINE, a class II device, cleared for Tecknam, Inc. on under FDA product code DLN (Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)). FDA records list one 510(k) clearance for Tecknam, Inc. As of , FDA records show no recalls naming K792429.

Clearance record

Decision date
Received
(9 days to decision)
Product code
DLN Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Tecknam, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DLN

Trailing 12 months

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

FDA records show no clearances under product code DLN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DLN, 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