510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K980776Substantially Equivalent

One Step Urine Drug of Abuse: Benzodiazepine Test

Tcpi, Inc., Simi Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980776 is the FDA 510(k) clearance record for ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST, a class II device, cleared for Tcpi, Inc. on under FDA product code JXM (Enzyme Immunoassay, Benzodiazepine). FDA records list one 510(k) clearance for Tcpi, Inc. As of , FDA records show no recalls naming K980776.

Clearance record

Decision date
Received
(58 days to decision)
Product code
JXM Enzyme Immunoassay, Benzodiazepine
Regulation
21 CFR 862.3170
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Tcpi, Inc. 1420 Los Angeles Ave. Suite 201, Simi Valley CA
510(k) summary
Summary
Third party review
No

Clearances, product code JXM

Trailing 12 months

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

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