510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923314Substantially Equivalent

Automates Coma Plus Cocaine Metabolite Assay

Serex, Inc., Maywood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923314 is the FDA 510(k) clearance record for AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY, a class II device, cleared for Serex, Inc. on under FDA product code JXO (Enzyme Immunoassay, Cocaine). FDA records list 2 510(k) clearances for Serex, Inc., from to . As of , FDA records show no recalls naming K923314.

Clearance record

Decision date
Received
(48 days to decision)
Product code
JXO Enzyme Immunoassay, Cocaine
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Serex, Inc. 230 W. Passaic St., Maywood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code JXO

Trailing 12 months

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

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