510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021526Substantially Equivalent

Acon Tca One Step Tricyclic Antidepressant Test Strip and Device

Acon Laboratories, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021526 is the FDA 510(k) clearance record for ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE, a class II device, cleared for ACON Laboratories, Inc. on under FDA product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs). FDA's definition for product code LFG reads: "Intended to measure any of the tricyclic antidepressant drugs in serum or urine". FDA records list 93 510(k) clearances for ACON Laboratories, Inc., from to . As of , FDA records show no recalls naming K021526.

Clearance record

Decision date
Received
(68 days to decision)
Product code
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Regulation
21 CFR 862.3910
Device class
Class II
Review panel
Clinical Toxicology
Applicant
ACON Laboratories, Inc. 4108 Sorrento Valley Blvd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFG

Trailing 12 months

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

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